Publications by authors named "Debra L Barton"

87 Publications

Fatigue, anxiety, and quality of life in breast cancer patients compared to non-cancer controls: a nationwide longitudinal analysis.

Breast Cancer Res Treat 2021 Jan 4. Epub 2021 Jan 4.

University of Rochester Medical Center, James P. Wilmot Cancer Institute, St. Jude Children's Research Hospital, Rochester, USA.

Purpose: Fatigue and anxiety are common and significant symptoms reported by cancer patients. Few studies have examined the trajectory of multidimensional fatigue and anxiety, the relationships between them and with quality of life.

Methods: Breast cancer patients (n = 580) from community oncology clinics and age-matched controls (n = 364) completed fatigue and anxiety questionnaires prior to chemotherapy (A1), at chemotherapy completion (A2), and six months post-chemotherapy (A3). Linear mixed models (LMM) compared trajectories of fatigue /anxiety over time in patients and controls and estimated their relationship with quality of life. Models adjusted for age, education, race, BMI, marital status, menopausal status, and sleep symptoms.

Results: Patients reported greater fatigue and anxiety compared to controls at all time points (p's < 0.001, 35% clinically meaningful anxiety at baseline). From A1 to A2 patients experienced a significant increase in fatigue (β = 8.3 95%CI 6.6,10.0) which returned to A1 values at A3 but remained greater than controls' (p < 0.001). General, mental, and physical fatigue subscales increased from A1 to A2 remaining significantly higher than A1 at A3 (p < 0.001). Anxiety improved over time (A1 to A3 β =  - 4.3 95%CI -2.6,-3.3) but remained higher than controls at A3 (p < 0.001). Among patients, fatigue and anxiety significantly predicted one another and quality of life. Menopausal status, higher BMI, mastectomy, and sleep problems also significantly predicted change in fatigue.

Conclusion: Breast cancer patients experience significant fatigue and anxiety up to six months post-chemotherapy that is associated with worse quality of life. Future interventions should simultaneously address anxiety and fatigue, focusing on mental and physical fatigue subdomains.
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http://dx.doi.org/10.1007/s10549-020-06067-6DOI Listing
January 2021

Trends in integrative medicine and health consults: differences between cancer survivors and patients without cancer.

Support Care Cancer 2020 Oct 14. Epub 2020 Oct 14.

Oregon Health & Science University, School of Nursing, 3455 SW US Veterans Hospital Rd, OR, 97239, Portland, USA.

Objectives: The objectives were to compare patients with and without cancer who sought an integrative health (IH) consult and reasons for seeking a consult.

Design: Descriptive cross-sectional study that employed a secondary analysis of an integrative health database supplemented by a retrospective medical record review.

Setting/location: Integrative Medicine and Health program in a Southwestern United States academic medical center.

Subjects: Eight hundred thirty-nine adults over the age of 18 seeking IH consultation.

Results: The number of complementary therapies reported prior to consult were not significantly different between groups. The most reported complementary therapies used by cancer survivors were multivitamins, exercise, and turmeric. Patients without cancer reported significantly higher pain levels than cancer survivors. Cancer survivors reported significantly higher energy, sleep levels, overall health, spiritual wellbeing, and significantly better relationships compared to patients without cancer. Cancer survivors reported fatigue and cancer as the top reasons for IH consult.

Conclusion: Participants without cancer reported higher levels of pain and lower levels of energy, sleep, overall health, spiritual wellbeing, and relationships compared to cancer survivors. However, cancer survivors still reported levels of unmanaged symptoms. Complementary therapy use prior to IMH consult was similar between groups; however, IMH providers recommended more treatments for patients without cancer. Our results highlight that more evidence is needed to guide IMH recommendations, especially for cancer survivors who may still be in treatment. Additionally, our results support evidence-based recommendations that all cancer survivors should be assessed for complementary therapy use and provided counseling by qualified providers on their advantages and limitations.
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http://dx.doi.org/10.1007/s00520-020-05815-0DOI Listing
October 2020

Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.

JMIR Res Protoc 2020 Sep 18;9(9):e19288. Epub 2020 Sep 18.

Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.

Background: Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.

Objective: This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation.

Methods: The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records.

Results: We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app.

Conclusions: This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes.

Trial Registration: ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844.

International Registered Report Identifier (irrid): PRR1-10.2196/19288.
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http://dx.doi.org/10.2196/19288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532463PMC
September 2020

A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance).

Support Care Cancer 2020 Dec 19;28(12):6085-6094. Epub 2020 Apr 19.

Mayo Clinic Cancer Center, Rochester, MN, USA.

Purpose: Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I).

Methods: This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint.

Results: Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms.

Conclusions: Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed.

Clinical Relevance: This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size.

Trial Registration: ClinicalTrials.gov identifier: NCT00993928.
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http://dx.doi.org/10.1007/s00520-020-05461-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572569PMC
December 2020

Side Effects, Self-Management Activities, and Adherence to Oral Anticancer Agents.

Patient Prefer Adherence 2019 31;13:2243-2252. Epub 2019 Dec 31.

University of Michigan School of Nursing, Ann Arbor, MI, USA.

Purpose: There are growing concerns about patients' adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine.

Methods: Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers. Severity of side effects related to capecitabine and effectiveness of self-management of side effects were captured using the Modified Self-Care Diary at the time of enrollment and weekly for 6 weeks. Spearman's correlation, Mann-Whitney -tests, and multiple linear regression were conducted, <0.05.

Results: Overall mean adherence rate was 85.4±14.1%. Adherence rate was not significantly correlated to the mean severity of total side effects at any time point and was correlated with the mean effectiveness of self-management of total side effects only at week 2 (=0.29, =0.04). However, adherence rate was associated with the mean severity of one specific side effect, diarrhea, at 6 weeks (=0.36, =0.01) and marginally correlated to the mean effectiveness of self-management of diarrhea at 6 weeks (=0.28, =0.05). Mean severity of diarrhea at 6 weeks was an independent predictor of adherence rate (=4.97, =0.01), with the control of age (=0.52, =0.002), number of outpatient medications (=1.12, =0.007), health literacy (=2.53, =0.04), diagnosis of colorectal cancer (=11.6, =0.03), and capecitabine in combination with other chemotherapies (=16.8, =0.001) in the model.

Conclusion: This pilot study suggests ongoing examination of both severity and effectiveness of self-management of side effects in future studies of adherence to OAAs is merited. There is a need for future studies with larger sample sizes that explore the complex relationships among adherence, severity of side effects, and effectiveness of self-management of side effects in OAA therapy.
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http://dx.doi.org/10.2147/PPA.S224496DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6997414PMC
December 2019

Yoga for Cancer-Related Fatigue in Survivors of Hematopoietic Cell Transplantation: A Feasibility Study.

J Pain Symptom Manage 2020 03 23;59(3):702-708. Epub 2019 Nov 23.

Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.

Context: Cancer-related fatigue (CRF) is one of the most common symptoms experienced by cancer patients after hematopoietic cell transplantation (HCT). Yoga is an approach with supportive evidence to improve CRF in different cancer populations, but to our knowledge, it has not been tested in an adult HCT population.

Objectives: The aim of this study was to evaluate the feasibility of a yoga intervention offered to adult HCT survivors with moderate-to-severe CRF.

Methods: This feasibility study used a single-arm, pretest-posttest design. Adult HCT survivors were enrolled in a six-week restorative yoga intervention that consisted of a one-hour once-weekly class with twice-weekly home practice using a DVD.

Results: Twenty participants (13 women and seven men) enrolled in this study with a mean age of 51 years (SD = 12.5). The sample consisted of 19 allogeneic HCT survivors, seven of whom had a history of acute graft-vs.-host disease (GVHD), six with active, extensive chronic GVHD, and one autologous HCT survivor. The accrual acceptance rate was 23.2% (20/86 HCT survivors) and retention rate was 60% (12/20). Overall adherence was 45.4%. No adverse events were reported.

Conclusion: The results of this study suggest that a restorative yoga intervention in adult HCT survivors is safe and feasible. The incidence of GVHD may have impacted adherence. Strategies to improve accrual acceptance, retention, and adherence are needed.
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http://dx.doi.org/10.1016/j.jpainsymman.2019.11.012DOI Listing
March 2020

Integrative Therapies for Cancer-Related Fatigue.

Cancer J 2019 Sep/Oct;25(5):349-356

Department of Family Medicine, University of Michigan Health System.

Cancer-related fatigue (CRF) is a common symptom for which cancer patients often use integrative and integrative therapies; however, evidence supporting these therapies is limited. The aim of this review is to provide evidence-based recommendations for integrative interventions during and after cancer treatment for CRF. These recommendations are based on a systematic literature review from 1990 through 2019. Cognitive behavior therapy plus hypnosis and American ginseng can be considered during active treatment, and acupressure, mindfulness-based cognitive therapy, and qigong/tai chi easy can be considered during posttreatment. Coenzyme Q10 and L-carnitine are not recommended during active-treatment. All other integrative therapies for CRF had insufficient evidence to make a recommendation. While there is increasing evidence for integrative therapies for CRF, because of lack of rigorous trials and replication, no therapies could be definitively recommended. Further rigorously designed integrative therapy research is needed and should consider implementation and dissemination.
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http://dx.doi.org/10.1097/PPO.0000000000000396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388739PMC
August 2020

The Use of Technology to Support Precision Health in Nursing Science.

J Nurs Scholarsh 2019 11 30;51(6):614-623. Epub 2019 Sep 30.

Chief, OEPCR and NINR Research Centers Program, National Institute of Nursing Research, Bethesda, MD, USA.

Purpose: This article outlines how current nursing research can utilize technology to advance symptom and self-management science for precision health and provides a roadmap for the development and use of technologies designed for this purpose.

Approach: At the 2018 annual conference of the National Institute of Nursing Research (NINR) Research Centers, nursing and interdisciplinary scientists discussed the use of technology to support precision health in nursing research projects and programs of study. Key themes derived from the presentations and discussion were summarized to create a proposed roadmap for advancement of technologies to support health and well-being.

Conclusions: Technology to support precision health must be centered on the user and designed to be desirable, feasible, and viable. The proposed roadmap is composed of five iterative steps for the development, testing, and implementation of technology-based/enhanced self-management interventions. These steps are (a) contextual inquiry, focused on the relationships among humans, and the tools and equipment used in day-to-day life; (b) value specification, translating end-user values into end-user requirements; (c) design, verifying that the technology/device can be created and developing the prototype(s); (d) operationalization, testing the intervention in a real-world setting; and (e) summative evaluation, collecting and analyzing viability metrics, including process data, to evaluate whether the technology and the intervention have the desired effect.

Clinical Relevance: Interventions using technology are increasingly popular in precision health. Use of a standard multistep process for the development and testing of technology is essential.
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http://dx.doi.org/10.1111/jnu.12518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147934PMC
November 2019

Phase II randomized controlled trial of hypnosis versus progressive muscle relaxation for body image after breast or gynecologic cancer.

Breast Cancer Res Treat 2019 Nov 9;178(2):357-365. Epub 2019 Aug 9.

Department of Internal Medicine - Hematology/Oncology, University of Michigan, Ann Arbor, MI, 48109, USA.

Background: Sexual dysfunction, fueled by body image stress, is prevalent in women with a history of breast or gynecologic cancer. Preliminary data support that mind-body connections may improve sexual health outcomes through improving body image.

Objective: This randomized controlled trial compared hypnosis to progressive muscle relaxation (PMR). The primary outcome was body image at week 6 as measured by the Impact of Treatment Scale for women who have or have had breast or gynecologic cancer.

Interventions/methods: Consented participants were randomized 2:1 to hypnosis or PMR. Both arms consisted of three face-to-face sessions delivered by a trained therapist. Sessions were every 2 weeks for 6 weeks; participants practiced at home between sessions using an audio recording.

Results: Eighty-seven women were randomized, 59 to hypnosis and 28 to PMR. Both groups reported significant improvements on body image over time (within group effect size Cohen's d = 0.49-0.75) with no significant difference between groups (p = 0.15). Secondary outcomes were not significantly different between groups. The hypnosis group improved more in sexual satisfaction and sexual interest while the PMR group improved more in positive affect.

Conclusions: Interventions facilitating mind-body connections such as hypnosis and PMR may help to improve body image. This study suggests that stress relieving strategies of hypnosis and PMR may contribute to providing a re-connection to one's body, improved positive affect, and overall better sexual health.
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http://dx.doi.org/10.1007/s10549-019-05395-6DOI Listing
November 2019

Impact of using a broad-based multi-institutional approach to build capacity for non-communicable disease research in Thailand.

Health Res Policy Syst 2019 Jun 14;17(1):62. Epub 2019 Jun 14.

Boromrajonani College of Nursing Nakon Lampang, 268 Pakham Road, Huawieng, Muang District, Lampang Province, 52000, Thailand.

Thailand's transition to high middle-income country status has been accompanied by demographic changes and associated shifts in the nation's public health challenges. These changes have necessitated a significant shift in public health focus from the treatment of infectious diseases to the more expensive and protracted management of non-communicable diseases (NCDs) in older adults.In 2010, in response to this shift in focus, the University of Michigan and colleagues at the Praboromarajchanok Institute for Health Workforce Development in Thailand began work on a broad-based multi-institutional programme for NCD research capacity-building in Thailand.To begin to build a base of intervention research we paired our programme's funded Thai postdoctoral fellows with United States mentors who have strong programmes of intervention research. One direct impact of the programme was the development of research 'hubs' focused upon similar areas of investigative focus such as self-management of cancer symptoms, self-management of HIV/AIDS and health technology information applications for use in community settings. Within these hubs, interventions with proven efficacy in the United States were used as a foundation for culturally relevant interventions in Thailand. The programme also aimed to develop the research support structures necessary within departments and colleges for grant writing and management, dissemination of new knowledge, and ethical conduct of human subject research.In an effort to capitalise on large national health datasets and big data now available in Thailand, several of the programme's postdoctoral fellows began projects that use data science methods to mine this asset. The investigators involved in these ground-breaking projects form the core of a network of research hubs that will be able to capitalise on the availability of lifespan health data from across Thailand and provide a robust working foundation for expansion of research using data science approaches.Going forward, it is vitally important to leverage this groundwork in order to continue fostering rapid growth in NCD research and training as well as to capitalise upon these early gains to create a sustaining influence for Thailand to lead in NCD research, improve the health of its citizens, and provide ongoing leadership in Southeast Asia.
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http://dx.doi.org/10.1186/s12961-019-0464-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6570856PMC
June 2019

Potential mediators of improvement in painful chemotherapy-induced peripheral neuropathy via a web-based cognitive behavioural intervention.

Can Oncol Nurs J 2018 1;28(3):178-183. Epub 2018 Jul 1.

Associate Professor, University of Michigan School of Nursing, Ann Arbor, MI, Email:

Purpose: Preliminary evidence suggests that a self-guided cognitive and behaviourally-based pain management intervention (PROSPECT) is effective for chronic painful chemotherapy-induced peripheral neuropathy (CIPN), but its mechanism of action is unknown. The purpose of this secondary analysis was to explore if changes in anxiety, depression, sleep-related impairment, or fatigue mediated improvements in worst pain following PROSPECT in individuals with chronic painful CIPN.

Methods: Sixty participants were randomized to receive self-guided cognitive behavioural pain management (access for eight weeks) or treatment as usual. A seven-day worst CIPN pain diary and the PROMIS measures of anxiety, depression, fatigue, and sleep-related impairment were administered pre/posttest (eight-weeks). Causal mediation analysis was used to quantify mediators of worst pain improvement.

Results: None of the hypothesized mediators had a statistically significant effect on worst pain (n=38).

Implications: Further research is needed to identify potential mediators of pain intensity that can be targeted by specific cognitive behavioural strategies to improve painful CIPN severity.
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http://dx.doi.org/10.5737/23688076283178183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6516921PMC
July 2018

Médiateurs potentiels d’amélioration de la neuropathie périphérique chimio-induite douloureuse par une intervention cognitivocomportementale en ligne.

Can Oncol Nurs J 2018 1;28(3):184-190. Epub 2018 Jul 1.

Professeurs adjointe, University of Michigan School of Nursing, Ann Arbor, M.I.; courriel :

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http://dx.doi.org/10.5737/23688076283184190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6516917PMC
July 2018

Factors influencing the use of extended adjuvant endocrine therapy.

Breast Cancer Res Treat 2019 May 31;175(1):181-189. Epub 2019 Jan 31.

Division of Oncology, Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Dr., #5513, Salt Lake City, UT, 84112, USA.

Purpose: Extending adjuvant endocrine therapy (ET) beyond 5 years has been shown to improve outcomes in breast cancer; however, limited data are available about if and why women pursue extended ET. The primary objective was to estimate the proportion of women who were willing to receive extended ET if recommended by their physician and secondarily, to determine what factors were associated with this decision.

Methods: This descriptive cross-sectional study surveyed 131 women with AJCC 7th Edition stages I-III breast cancer who had been taking adjuvant ET for 3-5 years. The survey inquired about the willingness to continue ET, quality of life (FACT-ES), and beliefs about medications (BMQ). Logistic regression was used to test for associations between clinical and disease factors, FACT-ES, BMQ, and the primary outcome.

Results: One hundred and twelve (85%) patients reported "moderate" (n = 30, 23%), "quite a bit" (n = 41, 31%), or "extreme" (n = 41, 31%) willingness to pursue extended ET; 19 (14%) patients were "not at all" or were "unlikely" to be willing to take extended ET. On univariate analysis, lower total and social well-being FACT-ES scores, and lower perceived necessity and higher concerns on BMQ were associated with lower willingness to pursue extended ET. On multivariable analysis, greater patient perception of necessity of ET was the only factor associated with willingness to pursue extended ET (OR 1.34, 95% CI 1.15-1.57, p = 0.0005).

Conclusions: Most women who have taken ET for multiple years report being willing to pursue extended ET if recommended. When discussing extended ET, the data from this study support exploring patients' belief of medication necessity.
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http://dx.doi.org/10.1007/s10549-019-05145-8DOI Listing
May 2019

Psychometric properties of the Menopause Specific Quality of Life questionnaire among Thai women with a history of breast cancer.

Eur J Oncol Nurs 2018 Oct 25;36:75-81. Epub 2018 Aug 25.

Department of Systems, Populations and Leadership, University of Michigan School of Nursing, University of Michigan, Michigan, 48109-5482, USA. Electronic address:

Purpose: This study evaluated the psychometric properties of the Thai Menopause Specific Quality of Life Questionnaire (MENQOL) instrument in menopausal Thai women with a history of breast cancer.

Methods: Two hundred and ninety women with a history of breast cancer who reported hot flashes completed the Thai MENQOL. Internal consistency reliability and item analysis were used to evaluate the reliability of the Thai MENQOL. Construct validity was evaluated by examining the correlations between the self-reported hot flash frequency and severity with the vasomotor MENQOL subscale (convergent validity); and assessed using exploratory factor analysis (structural validity).

Results: The Cronbach's alpha coefficient for the MENQOL total scale was 0.86 and for the vasomotor, psychosocial, physical, sexual domains were 0.73, 0.78, 0.81, and 0.83, respectively. Self-reported frequency and severity of hot flashes were correlated significantly with the vasomotor subscale (r's ≥ 0.50, p's < 0.001). The single item "increased facial hair" was poorly correlated with most items (r = 0.13). Confirmatory factor analysis supported four factors explaining 42.35% of the total variance. Item-domain correlation analysis showed that all items correlated more strongly with their own domains than with other domains.

Conclusions: The Thai version of the MENQOL demonstrates good psychometric properties (internal consistency reliability, convergent validity, and structural validity). We recommend removal of the single item, "increased facial hair" from the Thai version due to low correlations with most items. The Thai MENQOL can be used to measure menopause-related quality of life in Thai women with a history of breast cancer experiencing menopausal symptoms.
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http://dx.doi.org/10.1016/j.ejon.2018.08.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7093211PMC
October 2018

A cancer specific middle-range theory of symptom self-care management: A theory synthesis.

J Adv Nurs 2018 Dec 5;74(12):2935-2946. Epub 2018 Oct 5.

School of Nursing, University of Michigan, Ann Arbor, Michigan.

Aim: This article describes the development of a middle-range theory of symptom self-care management for adults with cancer.

Background: Current evidence indicates that people with cancer may benefit from engagement in self-care management behaviours, one of which is symptom management. A middle-range theory that explains and guides symptom self-care management in people with cancer is lacking.

Design: This paper combines and expands prior work related to symptom management and self-care management to introduce a newly synthesized theory of symptom self-care management for adult people with cancer. Walker and Avant's methodological approach was used to guide this theory synthesis.

Data Sources: PubMed, CINAHL, and Cochrane Library databases of peer reviewed journal articles published before 15 March 2018.

Implications For Nursing: The newly synthesized theory conceptualizes cancer as a chronic illness with related symptoms that persist beyond the acute phase of treatment. This theory sheds the light on self-care management as an essential approach to managing cancer-related symptoms and underscores the importance of empowering and enabling people with cancer to manage their symptoms in partnership with healthcare providers.

Conclusion: The new theory offers a comprehensive conceptualization of symptom self-care management behaviours in adults with cancer. It clarifies potential determinants and effects of cancer-related symptoms and puts forth factors that may influence patient adherence to symptom self-care management behaviours. This new theory may influence the development of symptom management interventions across the phases of the cancer self-care continuum. Research to test the new theory is warranted.
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http://dx.doi.org/10.1111/jan.13829DOI Listing
December 2018

Complementary therapies for fatigue after hematopoietic stem cell transplantation: an integrative review.

Bone Marrow Transplant 2018 05 16;53(5):556-564. Epub 2018 Jan 16.

School of Nursing, University of Michigan, Ann Arbor, MI, USA.

Fatigue after hematopoietic stem cell transplantation (HSCT) is a persistent problem that limits activities and causes distress. Complementary therapies have shown promising results in improving fatigue in several patient populations. However, it is unknown whether they have the same effect on fatigue in the HSCT population. This integrative review aimed to explore the literature that evaluated complementary therapies for fatigue among HSCT patients. Only eight studies were considered eligible for inclusion in this review. The eight studies evaluated music therapy, relaxation, mindfulness, and massage techniques with mixed results. These studies had major methodological limitations, such as the small sample sizes and not blinding participants to the treatment allocation, introducing possible bias. Furthermore, most of these studies used 'usual care' control groups, leaving it unclear to what extent the observed effects are based on the effects of complementary therapies, or rather on psychosocial factors such as personal attention. More research is needed to more rigorously evaluate these and other complementary therapies for the prevalent problem of fatigue in the HSCT population.
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http://dx.doi.org/10.1038/s41409-017-0073-5DOI Listing
May 2018

Acceptance and Use of eHealth/mHealth Applications for Self-Management Among Cancer Survivors.

Stud Health Technol Inform 2017 ;245:131-135

School of Nursing, University of Michigan, Ann Arbor, Michigan, USA.

Cancer survivors' acceptance and use of eHealth/mHealth applications for self-management can be unique and are not fully understood. We used data from the Health Information National Trends Survey 4 Cycle 4 to examine cancer survivors' acceptance and use of eHealth/mHea applications for key self-management processes, and conducted logistic regression and Rao-Scott design-adjusted Chi-square tests to assess bivariate associations between potential predictors and actual use. Potential factors were selected based on the Individual and Family Self-Management theory. High acceptance of eHealth applictions was identified, and adoption of mHealth was relatively low. Younger, higher educated, married, employed, and higher income survivors tended to use eHealth/mHealth applications for self-management. Survivors who were newly diagnosed or still on treatment were more likely to look for cancer information online or communicate with health providers electronically. BMI and rural residency were associated with use of mHealth apps to achieve a health-related goal and treatment decision-making.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6180909PMC
June 2018

Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy: A Multicenter, Pilot, Randomized, Wait-List Controlled Trial.

J Pain 2018 04 8;19(4):382-394. Epub 2017 Dec 8.

St. Joseph Mercy Hospital, Ann Arbor, Michigan.

The purpose of this pilot, parallel, randomized controlled trial was to examine the efficacy of a self-guided online cognitive and behaviorally-based pain management intervention (Proactive Self-Management Program for Effects of Cancer Treatment [PROSPECT]) to reduce "worst" pain for individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN). Secondary outcomes included "average" pain, nonpainful CIPN symptom severity, impression of change, and pain interference. Sixty patients with chronic painful CIPN were recruited from 5 outpatient academic and community cancer centers. Patients were randomized in a 1:1 ratio to receive either 8 weeks of PROSPECT or usual care. A 7-day electronic "worst" pain intensity diary and standardized measures of pain interference, nonpainful CIPN symptom severity, impression of change, and "average" pain were administered pre/post intervention. Postintervention mean scores were evaluated between groups using analysis of covariance adjusting for baseline. Individuals who received the PROSPECT intervention (n = 19) had significantly greater improvements in "worst pain" compared with individuals receiving usual care (n = 19; P = .046, d = .58). There were no significant differences in mean scores between groups for the secondary outcomes (n = 42). A larger, adequately powered study testing the PROSPECT intervention is needed to determine if improvements in pain may be sustained, evaluate the effect of the intervention on the secondary outcomes, and identify mediators of pain intensity-related improvement.

Perspective: This study explores the efficacy of an 8-week online cognitive behavioral pain management intervention for chronic painful CIPN. Intervention use resulted in greater improvements in "worst" pain than usual care alone. The findings provide preliminary support for the efficacy of a nonpharmacological intervention for chronic painful CIPN.
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http://dx.doi.org/10.1016/j.jpain.2017.11.009DOI Listing
April 2018

Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline.

J Clin Oncol 2018 02 11;36(5):492-511. Epub 2017 Dec 11.

Jeanne Carter, Katherine DuHamel, and Shari Goldfarb, Memorial Sloan Kettering Cancer Center, New York; Michael A. Diefenbach, Northwell Health, Manhasset, NY; Christina Lacchetti, American Society of Clinical Oncology, Alexandria; Sage Bolte, Inova, Fairfax, VA; Barbara L. Andersen, Ohio State University, Columbus, OH; Debra L. Barton, University of Michigan, Ann Arbor, MI; Shari Damast, Yale School of Medicine, New Haven, CT; Judith Florendo, Florendo Physical Therapy, Chicago; Sigrun Hallmeyer, Oncology Specialists SC, Park Ridge, IL; Patricia A. Ganz, University of California, Los Angeles, CA; David M. Kushner, University of Wisconsin, Madison, WI; and Julia H. Rowland, National Cancer Institute, Bethesda, MD.

Purpose The adaptation of the Cancer Care Ontario (CCO) guideline Interventions to Address Sexual Problems in People With Cancer provides recommendations to manage sexual function adverse effects that occur as a result of cancer diagnosis and/or treatment. Methods ASCO staff reviewed the guideline for developmental rigor and updated the literature search. An ASCO Expert Panel ( Table A1 ) was assembled to review the guideline content and recommendations. Results The ASCO Expert Panel determined that the recommendations from the 2016 CCO guideline are clear, thorough, and based upon the most relevant scientific evidence. ASCO statements and modifications were added to adapt the CCO guideline for a broader audience. Recommendations It is recommended that there be a discussion with the patient, initiated by a member of the health care team, regarding sexual health and dysfunction resulting from cancer or its treatment. Psychosocial and/or psychosexual counseling should be offered to all patients with cancer, aiming to improve sexual response, body image, intimacy and relationship issues, and overall sexual functioning and satisfaction. Medical and treatable contributing factors should be identified and addressed first. In women with symptoms of vaginal and/or vulvar atrophy, lubricants in addition to vaginal moisturizers may be tried as a first option. Low-dose vaginal estrogen, lidocaine, and dehydroepiandrosterone may also be considered in some cases. In men, medication such as phosphodiesterase type 5 inhibitors may be beneficial, and surgery remains an option for those with symptoms or treatment complications refractory to medical management. Both women and men experiencing vasomotor symptoms should be offered interventions for symptomatic improvement, including behavioral options such as cognitive behavioral therapy, slow breathing and hypnosis, and medications such as venlafaxine and gabapentin.Additional information is available at: www.asco.org/survivorship-guidelines and www.asco.org/guidelineswiki .
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http://dx.doi.org/10.1200/JCO.2017.75.8995DOI Listing
February 2018

Systemic and local effects of vaginal dehydroepiandrosterone (DHEA): NCCTG N10C1 (Alliance).

Support Care Cancer 2018 Apr 21;26(4):1335-1343. Epub 2017 Nov 21.

Mayo Clinic, Rochester, MN, USA.

Background: Dehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history.

Methods: Postmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3.25 versus 6.5 mg/day of DHEA versus a plain moisturizer (PM) control. Sex steroid hormone levels, biomarkers of bone formation, vaginal pH, and maturation index were collected at baseline and 12 weeks. Analysis included independent t tests and Wilcoxon rank tests, comparing each DHEA arm with the control.

Results: Three hundred forty-five women contributed evaluable blood and 46 contributed evaluable cytology and pH values. Circulating DHEA-S and testosterone levels were significantly increased in those on vaginal DHEA in a dose-dependent manner compared to PM. Estradiol was significantly increased in those on 6.5 mg/day DHEA but not in those on 3.25 mg/day DHEA (p < 0.05 and p = 0.05, respectively), and not in those on AIs. Biomarkers of bone formation were unchanged in all arms. Maturation of vaginal cells was 100% (3.25 mg/day), 86% (6.5 mg/day), and 64% (PM); pH decreased more in DHEA arms.

Conclusion: DHEA resulted in increased hormone concentrations, though still in the lowest half or quartile of the postmenopausal range, and provided more favorable effects on vaginal cytology, compared to PM. Estrogen concentrations in women on AIs were not changed. Further research on the benefit of vaginal DHEA is warranted in hormone-dependent cancers.
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http://dx.doi.org/10.1007/s00520-017-3960-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5823730PMC
April 2018

Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors: NCCTG N10C1 (Alliance).

Support Care Cancer 2018 02 18;26(2):643-650. Epub 2017 Sep 18.

Mayo Clinic, Rochester, MN, USA.

Background: Women with estrogen deficiencies can suffer from vaginal symptoms that negatively impact sexual health. This study evaluated vaginal dehydroepiandrosterone (DHEA) for alleviation of vaginal symptoms.

Methods: This three-arm randomized, controlled trial evaluated DHEA 3.25 mg and DHEA 6.5 mg, each compared to a plain moisturizer (PM) over 12 weeks, to improve the severity of vaginal dryness or dyspareunia, measured with an ordinal scale, and overall sexual health using the Female Sexual Function Index (FSFI). Postmenopausal women with a history of breast or gynecologic cancer who had completed primary treatment, had no evidence of disease, and reported at least moderate vaginal symptoms were eligible. The mean change from baseline to week 12 in the severity of vaginal dryness or dyspareunia for each DHEA dose was compared to PM and analyzed by two independent t tests using a Bonferroni correction.

Results: Four hundred sixty-four women were randomized. All arms reported improvement in either dryness or dyspareunia. Neither DHEA dose was statistically significantly different from PM at 12 weeks (6.25 mg, p = .08; 3.25 mg, p = 0.48), although a significant difference at 8 weeks for 6.5 mg DHEA was observed (p = 0.005). Women on the 6.5 mg arm of DHEA reported significantly better sexual health on the FSFI (p < 0.001). There were no significant differences in provider-graded toxicities and few significant differences in self-reported side effects.

Conclusion: PM and DHEA improved vaginal symptoms at 12 weeks. However, vaginal DHEA, 6.5 mg, significantly improved sexual health. Vaginal DHEA warrants further investigation in women with a history of cancer.
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http://dx.doi.org/10.1007/s00520-017-3878-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5754227PMC
February 2018

Functional status and quality of life among breast cancer survivors with heart failure: results of the Medicare Health Outcomes Survey.

Support Care Cancer 2017 08 8;25(8):2463-2473. Epub 2017 Mar 8.

Department of Systems, Populations, and Leadership, School of Nursing, University of Michigan, Ann Arbor, MI, USA.

Purpose: The purpose of this population-based study was to examine health-related quality of life (HRQOL) and functional status among breast cancer survivors with heart failure.

Methods: We examined Medicare Health Outcomes Survey data from women aged 65 and older diagnosed with breast cancer in the past 5 years. Surveys were linked to Surveillance, Epidemiology, and End Results cancer registries. Each woman identified with self-reported heart failure (n = 239) was matched to controls without heart failure (n = 685) using propensity scores. The Short Form-36/Veterans Rand-12 measured eight domains of HRQOL. Functional status impairment was measured by limitations in six activities of daily living (ADLs). Linear models estimated associations between heart failure status and HRQOL. Logistic regression models estimated odds ratios for associations between heart failure and ADL impairment. We examined associations for the total study population and subgroups stratified by cancer stage.

Results: Among all study participants, heart failure was associated with significant deficits in every HRQOL domain and impairment in all ADLs (p < 0.01, ORs ranged from 1.74 to 2.47). After stratification by cancer stage, heart failure was associated with physical HRQOL deficits across all cancer stages (physical function, vitality, general health) and mental HRQOL deficits only in women with stage I/II cancer (role-emotional, social function). Women with early stage cancer experienced the greatest HRQOL deficits associated with heart failure.

Conclusions: Heart failure in breast cancer survivors is associated with substantial HRQOL deficits and functional status impairment, particularly in early stage cancer. Tailored interventions are needed to improve physical function and mental wellbeing in this high-risk population.
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http://dx.doi.org/10.1007/s00520-017-3653-4DOI Listing
August 2017

Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

Menopause 2017 Jul;24(7):774-782

1University of Michigan, School of Nursing, Ann Arbor, MI 2Mayo Clinic, Rochester, MN 3University of Texas, Austin, TX 4Baylor University, Waco, TX.

Objective: The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction.

Methods: Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes.

Results: The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study.

Conclusions: Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.
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http://dx.doi.org/10.1097/GME.0000000000000837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5747247PMC
July 2017

Older Adults at Risk for Atrial Fibrillation Lack Knowledge and Confidence to Seek Treatment for Signs and Symptoms.

SAGE Open Nurs 2017 Jan-Dec;3. Epub 2017 Aug 29.

College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.

Early detection of atrial fibrillation (AF) is crucial for averting AF-related stroke and heart failure, but treatment is delayed when AF is not recognized. The critical need for early detection and treatment requires education to promote AF awareness. Knowledge deficits, attitudes, and beliefs about AF that should be addressed to improve awareness and reduce treatment-seeking delay in older adults at risk for developing AF have not been well documented. The purpose of this study was to describe knowledge, treatment-seeking attitudes, and beliefs about AF in adults ⩾ 65 years old and identify demographic characteristics associated with knowledge, attitudes, and beliefs. Patients with no history of AF recruited from an academic medical center were interviewed using the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey. Data were analyzed using descriptive statistics and independent tests. Participants ( = 180) were 63% male with a mean age of ±3.± 6.0 years, and 52% held ⩾ 4-year college degree. About one third could not identify common symptoms of AF including palpitations (31%), chest pain (36%), dyspnea (30%), and fatigue (35%). A majority (84%) lacked confidence to recognize AF, and 58% were not sure when they should seek care for AF symptoms. Nearly a third (32%) believed palpitations are always present with AF, and 74% believed that low energy would not be their only symptom of AF. Higher scores for AF Symptom Knowledge ( = .02) were observed in females, and General Knowledge about AF was greater for younger participants ( < .001). Participants lacked knowledge and confidence to aid decision-making for treatment-seeking for symptoms of AF and held inaccurate beliefs about AF that could hinder early treatment-seeking. Programs to promote AF awareness should explain the spectrum of symptoms that may be manifested by AF and include action plans for responding to symptoms.
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http://dx.doi.org/10.1177/2377960817720324DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326385PMC
August 2017

Feasibility Testing of the Alert for AFib Intervention.

West J Nurs Res 2017 Feb 11;39(2):252-272. Epub 2016 Jul 11.

4 University of Illinois at Chicago, Chicago, IL, USA.

Improving early detection and treatment of atrial fibrillation (AF) is critical because untreated AF is a major contributor to stroke and heart failure. We sought to generate knowledge about the feasibility of conducting a randomized controlled trial to test the effect of the Alert for AFib intervention on knowledge, attitudes, and beliefs about treatment-seeking for signs and symptoms of AF. Adults ≥65 years old (96% White) at risk for developing AF were randomized to receive the Alert for AFib intervention ( n = 40) or an attention control session ( n = 40). Feasibility goals for recruitment, participant retention, adherence, perceived satisfaction and burden, and intervention fidelity were met. From baseline to study completion, knowledge ( p = .005) and attitudes ( p < .001) about treatment-seeking improved more in the intervention group compared with the control group. Results support testing the effectiveness of the Alert for AFib intervention in a large trial.
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http://dx.doi.org/10.1177/0193945916656609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5347363PMC
February 2017

Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline.

J Clin Oncol 2016 09 23;34(25):3069-103. Epub 2016 May 23.

Hope S. Rugo, University of California San Francisco Comprehensive Cancer Center; Barbara Fowble, University of California San Francisco, San Francisco; Rita S. Mehta, University of California Irvine, Orange, CA; R. Bryan Rumble, American Society of Clinical Oncology, Alexandria; James L. Khatcheressian, Virginia Cancer Institute, Richmond, VA; Erin Macrae, Columbus Oncology and Hematology Associates, Columbus, OH; Debra L. Barton, University of Michigan School of Nursing, Ann Arbor, MI; Hannah Klein Connolly, Patient Representative, Edina, MN; Maura N. Dickler, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Lesley Fallowfield, Sussex Health Outcomes Research and Education in Cancer, Brighton and Sussex Medical School, University of Sussex, Sussex; Stephen R.D. Johnston, Royal Marsden Hospital, London, United Kingdom; James N. Ingle, Mayo Clinic, Rochester, MN; Mohammad Jahanzeb, University of Miami Sylvester Comprehensive Cancer Center, Deerfield Beach, FL; Larissa A. Korde, University of Washington, Seattle, WA; Hyman B. Muss, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; and Harold J. Burstein, Dana-Farber Cancer Center, Boston, MA.

Purpose: To develop recommendations about endocrine therapy for women with hormone receptor (HR) -positive metastatic breast cancer (MBC).

Methods: The American Society of Clinical Oncology convened an Expert Panel to conduct a systematic review of evidence from 2008 through 2015 to create recommendations informed by that evidence. Outcomes of interest included sequencing of hormonal agents, hormonal agents compared with chemotherapy, targeted biologic therapy, and treatment of premenopausal women. This guideline puts forth recommendations for endocrine therapy as treatment for women with HR-positive MBC.

Recommendations: Sequential hormone therapy is the preferential treatment for most women with HR-positive MBC. Except in cases of immediately life-threatening disease, hormone therapy, alone or in combination, should be used as initial treatment. Patients whose tumors express any level of hormone receptors should be offered hormone therapy. Treatment recommendations should be based on type of adjuvant treatment, disease-free interval, and organ function. Tumor markers should not be the sole criteria for determining tumor progression; use of additional biomarkers remains experimental. Assessment of menopausal status is critical; ovarian suppression or ablation should be included in premenopausal women. For postmenopausal women, aromatase inhibitors (AIs) are the preferred first-line endocrine therapy, with or without the cyclin-dependent kinase inhibitor palbociclib. As second-line therapy, fulvestrant should be administered at 500 mg with a loading schedule and may be administered with palbociclib. The mammalian target of rapamycin inhibitor everolimus may be administered with exemestane to postmenopausal women with MBC whose disease progresses while receiving nonsteroidal AIs. Among patients with HR-positive, human epidermal growth factor receptor 2-positive MBC, human epidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates.
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http://dx.doi.org/10.1200/JCO.2016.67.1487DOI Listing
September 2016

Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.

Support Care Cancer 2016 Mar 8;24(3):1061-9. Epub 2015 Aug 8.

School of Nursing, University of Michigan, 400 N. Ingalls, Room 2153, Ann Arbor, MI, 48109, USA.

Purpose: Hot flashes are a significant source of symptom burden that negatively impacts quality of life (QOL). For women who have contraindications to, or are unwilling to consider, estrogens or antidepressants for bothersome hot flashes, there are limited effective pharmacologic or complementary and alternative medicines.

Methods: This single-arm phase II trial studied the efficacy of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes. Eligible women were required to have reported ≥14 hot flashes per week for ≥1 month. The patients were treated with SAMe at a dose of 400 mg twice daily to evaluate whether a reduction in hot flash score appeared to be better than the historical placebo response of approximately 25%. The women kept a daily hot flash diary during a baseline week and then daily during weeks 2-7. The primary endpoint was the change from baseline to week 7 in hot flash score and hot flash frequency. Secondary endpoints included toxicity analyses and the effect of SAMe on QOL.

Results: From October 28, 2010 to January 30, 2012, 43 women were treated with SAMe. The decrease in mean percent of baseline hot flash score and frequency was 35.4 and 32.6%, respectively. When compared to the historical placebo response of 25%, the effect of SAMe on hot flash score was not statistically significant (p = 0.09). Treatment was well tolerated with expected grade 1/2 gastrointestinal toxicity and no negative effect on QOL.

Conclusions: The use of SAMe does not appear to significantly reduce hot flashes more than would be expected with a placebo.
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http://dx.doi.org/10.1007/s00520-015-2878-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4973573PMC
March 2016

Symptoms: Menopause, Infertility, and Sexual Health.

Adv Exp Med Biol 2015 ;862:115-41

Mary Lou Willard French Professor of Nursing, University of Michigan School of Nursing, Ann Arbor, MI, USA,

By 2022, the number of survivors is expected to grow to nearly 18 million. Therefore, addressing acute and chronic negative sequelae of a cancer diagnosis and its treatments becomes a health imperative. For women with a history of breast cancer, one of the common goals of treatment and prevention of recurrence is to reduce circulating concentrations of estradiol, especially in women with hormone receptor positive breast cancer. Hormone deprivation after a diagnosis of breast cancer impacts physiological targets other than in the breast tissue and can result in unwanted side effects, all of which can negatively impact quality of life and function and cause distress. Symptoms that are most strongly linked by evidence to hormone changes after cancer diagnosis and treatment include hot flashes, night sweats, sleep changes, fatigue, mood changes, and diminishing sexual function, including vaginal atrophy (decreased arousal, dryness and dyspareunia), infertility, decreased desire and negative self-image. Weight gain and resulting body image changes are often concomitants of the abrupt onset of treatment-induced menopause. The purpose of this chapter is to briefly review what is known about the advent of premature menopause in women treated for breast cancer, menopausal symptoms that are exacerbated by endocrine treatments for breast cancer, and the associated concerns of hot flashes and related menopausal symptoms, sexual health and fertility issues. We will discuss limitations in the current research and propose strategies that address current limitations in order to move the science forward.
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http://dx.doi.org/10.1007/978-3-319-16366-6_9DOI Listing
October 2015

North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.

Menopause 2015 Jun;22(6):627-32

From the 1Virginia Commonwealth University, Richmond, VA; 2Alliance Statistics and Data Center, Mayo Clinic Rochester, Rochester, MN; 3Johns Hopkins Medical Institutions, Baltimore, MD; 4University of Michigan School of Nursing, Ann Arbor, MI; 5Colorado Cancer Research Program, Denver, CO; 6Wichita Community Clinical Oncology Program, Wichita, KS; 7Metro-Minnesota Community Clinical Oncology Program, St Louis Park, MN; 8Michigan Cancer Research Consortium, Ann Arbor, MI; 9Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL; 10Grand Rapids Clinical Oncology Program, Grand Rapids, MI; and 11Mayo Clinic, Rochester, MN.

Objective: Hot flashes are a common symptom in breast cancer survivors that can negatively impact quality of life. Preliminary data suggested that magnesium might be used as an effective low-cost treatment of hot flashes with minimal adverse effects.

Methods: A four-arm, double-blind, placebo-controlled, randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome hot flashes were randomized into treatment groups of magnesium oxide 800 or 1,200 mg daily or corresponding placebo groups at a 2:2:(1:1) ratio. Hot flash frequency and hot flash score (number × mean severity) were measured using a validated hot flash diary. A 1-week baseline period preceded initiation of study medication. The primary endpoint was intrapatient difference in mean hot flash score between baseline and treatment periods, comparing each magnesium group with the combined placebo groups using a gatekeeping procedure. Results were analyzed using repeated-measures and growth curve models on weekly hot flash scores based on a modified intent-to-treat principle.

Results: Two hundred eighty-nine women enrolled between December 2011 and March 2013. Study groups were well balanced for baseline characteristics. Mean hot flash scores, mean hot flash frequencies, and associated changes during the treatment period were similar for each group. An increased incidence of diarrhea and a corresponding lower incidence of constipation were reported in magnesium arms compared with placebo. No statistically significant difference in other toxicities or quality-of-life measures was observed.

Conclusions: The results of this trial do not support the use of magnesium oxide for hot flashes.
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http://dx.doi.org/10.1097/GME.0000000000000374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4442087PMC
June 2015

OMERACT-based fibromyalgia symptom subgroups: an exploratory cluster analysis.

Arthritis Res Ther 2014 Oct 16;16(5):463. Epub 2014 Oct 16.

Introduction: The aim of this study was to identify subsets of patients with fibromyalgia with similar symptom profiles using the Outcome Measures in Rheumatology (OMERACT) core symptom domains.

Methods: Female patients with a diagnosis of fibromyalgia and currently meeting fibromyalgia research survey criteria completed the Brief Pain Inventory, the 30-item Profile of Mood States, the Medical Outcomes Sleep Scale, the Multidimensional Fatigue Inventory, the Multiple Ability Self-Report Questionnaire, the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) and the Short Form-36 between 1 June 2011 and 31 October 2011. Hierarchical agglomerative clustering was used to identify subgroups of patients with similar symptom profiles. To validate the results from this sample, hierarchical agglomerative clustering was repeated in an external sample of female patients with fibromyalgia with similar inclusion criteria.

Results: A total of 581 females with a mean age of 55.1 (range, 20.1 to 90.2) years were included. A four-cluster solution best fit the data, and each clustering variable differed significantly (P <0.0001) among the four clusters. The four clusters divided the sample into severity levels: Cluster 1 reflects the lowest average levels across all symptoms, and cluster 4 reflects the highest average levels. Clusters 2 and 3 capture moderate symptoms levels. Clusters 2 and 3 differed mainly in profiles of anxiety and depression, with Cluster 2 having lower levels of depression and anxiety than Cluster 3, despite higher levels of pain. The results of the cluster analysis of the external sample (n = 478) looked very similar to those found in the original cluster analysis, except for a slight difference in sleep problems. This was despite having patients in the validation sample who were significantly younger (P <0.0001) and had more severe symptoms (higher FIQ-R total scores (P = 0.0004)).

Conclusions: In our study, we incorporated core OMERACT symptom domains, which allowed for clustering based on a comprehensive symptom profile. Although our exploratory cluster solution needs confirmation in a longitudinal study, this approach could provide a rationale to support the study of individualized clinical evaluation and intervention.
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http://dx.doi.org/10.1186/s13075-014-0463-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221670PMC
October 2014