Showing papers by "Melinda L. Irwin published in 2017"

Effect of the LIVESTRONG at the YMCA exercise program on physical activity, fitness, quality of life, and fatigue in cancer survivors

Abstract: BACKGROUND Physical activity (PA) has been linked to a lower risk of developing and dying of cancer, yet many cancer survivors do not exercise. In the current study, the authors evaluated the impact of the LIVESTRONG at the YMCA exercise program, available at Young Men's Christian Associations (YMCAs) across the United States, on PA, fitness, quality of life, fatigue, body composition, serum biomarkers, and program safety in cancer survivors. METHODS Cancer survivors were recruited through the Yale Cancer Center and the Dana-Farber Cancer Institute and randomized to a 12-week, twice-weekly LIVESTRONG at the YMCA exercise program at YMCAs in Connecticut or Massachusetts or to a control group. Questionnaires, dual-energy x-ray absorptiometry scans, 6-minute walk tests (6MWTs), and a fasting blood draw were completed at baseline and at 12 weeks. Intervention effects were evaluated using mixed model repeated measures analysis, with changes at 12 weeks in PA and 6MWT as the primary endpoints. RESULTS A total of 186 participants were randomized (95 to the exercise group and 91 to the control group). The majority of patients were diagnosed with AJCC stage I to II cancer and 53% had breast cancer. Participants randomized to the LIVESTRONG at the YMCA program experienced increases in PA (71% exercising at ≥ 150 minutes/week vs 26% of controls; P<.05) and improvements in the 6MWT (group difference: 28.9 meters [95% confidence interval, 0.3-49.0; P = .004]) and quality of life (group difference: 2.6 [95% confidence interval, 0.1-5.0; P = .04]). No adverse events were reported. CONCLUSIONS The LIVESTRONG at the YMCA exercise program has the potential to impact thousands of survivors across the YMCA network and could lead to improvements in disease and psychosocial outcomes in the growing population of cancer survivors. Cancer 2017;123:1249–1258. © 2016 American Cancer Society.

The effect of exercise on body composition and bone mineral density in breast cancer survivors taking aromatase inhibitors.

Abstract: Objective This study examined the effect of 12 months of aerobic and resistance exercise versus usual care on changes in body composition in postmenopausal breast cancer survivors taking aromatase inhibitors (AIs). Methods The Hormones and Physical Exercise study enrolled 121 breast cancer survivors and randomized them to either supervised twice-weekly resistance exercise training and 150 min/wk of aerobic exercise (N = 61) or a usual care (N = 60) group. Dual-energy X-ray absorptiometry scans were conducted at baseline, 6 months, and 12 months to assess changes in body mass index, percent body fat, lean body mass, and bone mineral density. Results At 12 months, the exercise group relative to the usual care group had a significant increase in lean body mass (0.32 vs. −0.88 kg, P = 0.03), a decrease in percent body fat (−1.4% vs. 0.48%, P = 0.03), and a decrease in body mass index (−0.73 vs. 0.17 kg/m2, P = 0.03). Change in bone mineral density was not significantly different between groups at 12 months (0.001 vs. −0.006 g/cm2, P = 0.37). Conclusions A combined resistance and aerobic exercise intervention improved body composition in breast cancer survivors taking AIs. Exercise interventions may help to mitigate the negative side effects of AIs and improve health outcomes in breast cancer survivors.

Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design.

Abstract: Excess body weight is a poor prognostic factor in women with early breast cancer, but the effect of weight loss on the risk of breast cancer recurrence and mortality in women who are overweight or obese at the time of breast cancer diagnosis has not been evaluated. The Alliance for Clinical Trials in Oncology Breast Cancer Weight Loss trial, also known as A011401, is testing the impact of a telephone-based weight loss program on invasive disease-free survival in 3136 women with a body mass index ≥27 kg/m2 who have recently been diagnosed with stage II-III, HER-2 negative breast cancer. Secondary outcomes of the trial include the impact of the weight loss intervention on overall survival, body weight, physical activity, dietary intakes, incidence of comorbidities, serum biomarkers and patient reported outcomes. Participants are randomized 1:1 to a 2-year, telephone-based weight loss intervention or to an education control group. The intervention is delivered through 42 telephone calls, delivered by health coaches based at the Dana-Farber Cancer Institute. Calls are supplemented by an intervention workbook, as well as a number of tools to help facilitate weight loss. Intervention goals include loss of 10% of baseline body weight, achieved through caloric restriction and increased physical activity. This large-scale study testing the impact of purposeful weight loss after cancer diagnosis on the risk of breast cancer recurrence and mortality has the potential to make weight loss programs a standard part of breast cancer treatment.

Randomized Trial of Exercise on Quality of Life in Women With Ovarian Cancer: Women's Activity and Lifestyle Study in Connecticut (WALC).

Abstract: Background Ovarian cancer survivors experience a wide range of treatment side effects that can negatively affect health-related quality of life (HRQOL) Physical activity has been shown to improve HRQOL and cancer-related fatigue (CRF) for other cancer survivors; however, no large randomized controlled trial (RCT) has been conducted for ovarian cancer Methods This study examined the impact of a six-month RCT of exercise vs attention control on change in HRQOL (Short Form Health Survey-36) and CRF (Functional Assessment of Cancer Therapy-Fatigue Scale) in ovarian cancer survivors Women (n = 144) were randomly assigned to study arms between May 1, 2010, and March 20, 2014 All statistical tests were two-sided Results A total of 74 women were randomly assigned to exercise and 70 to attention control A total of 113 (785%) of the participants completed the six-month assessment Adherence to the exercise intervention was excellent (1660±661 minutes/week in the exercise arm) At six months, women in the exercise arm had improved physical HRQOL (SF-36 Physical Component Summary Score) compared with the control arm, 18 (SD = 11) vs -20 (SD = 12) , respectively (group difference = 37, SD = 12, 95% confidence interval [CI] = 07 to 68, P = 02) No group differences were seen for change in mental HRQOL There was a statistically significant improvement in the fatigue score (Functional Assessment of Cancer Therapy-Fatigue) for exercisers (40, SD = 11, 95% CI = 18 to 62, P < 001) but not for controls (12, SD = 12, 95% CI = -11 to 35, P = 31), with a between-group difference of 28 (SD = 15, 95% CI = -02 to 57, P = 06) Conclusions We found a six-month home-based, telephone-delivered exercise intervention of primarily brisk walking to be associated with improved physical HRQOL in women with ovarian cancer Given that higher HRQOL and exercise have both been associated with overall survival in women diagnosed with ovarian cancer, oncologists and primary care providers should recommend and refer women diagnosed with ovarian cancer to clinic- or community-based exercise programs

Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes

Abstract: Introduction Mobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes. Methods and analysis The Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP 1C ) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA 1C Ethics and dissemination The central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications. Trial registration number CHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.

Post-diagnosis body mass index and mortality among women diagnosed with endometrial cancer: Results from the Women’s Health Initiative

Abstract: Higher body mass index (BMI) measured before endometrial cancer diagnosis has been associated with greater risk of developing endometrial cancer and higher mortality, but the association between BMI measured after diagnosis and mortality risk is unclear. We identified 467 women (91 deaths) in the Women's Health Initiative (WHI) with information on BMI measured after diagnosis and used Cox proportional hazards regression to generate hazard ratios (HR) and 95% confidence intervals (CI) for all-cause mortality. Comparing BMI 35+ with <25 kg/m2, we observed no association with all-cause mortality (HR = 1.02, 95% CI 0.55-1.91). Our study does not support the hypothesis that higher BMI after endometrial cancer diagnosis is associated with poorer survival.

Abstract S5-05: Impact of pre-operative exercise on breast cancer gene expression

Abstract: Background: Exercise is linked to a lower risk of developing and dying from breast cancer, but the biological mechanisms through which exercise could impact breast cancer are unclear. In animal models, exercise impacts tumor formation and progression, but there are few data regarding direct effects of exercise on tumor tissue in humans. The Pre-Operative Health and Body (PreHAB) Study was a randomized window of opportunity trial designed to explore the impact of exercise on molecular pathways in women with breast cancer. Methods: Inactive women with Stage I-III breast cancer were enrolled through Dana-Farber Cancer Institute and Yale University prior to surgery. Participants were randomized 1:1 to an aerobic and strength training exercise intervention or mind body control intervention and participated in the interventions between enrollment and the time of surgery. Tumor tissue was collected at enrollment and surgery; samples were reviewed by a breast pathologist and were macrodissected to include sections of tumor with at least 10% cellularity. Capture RNA-sequencing of the transcriptome coding regions was performed using the Illumina Truseq RNA access platform. Results: 49 women were randomized (27 exercise and 22 control). At baseline, mean age was 52.6, BMI was 30.2kg/m2 and exercise was 49 min/wk. Mean time between enrollment and surgery was 4.2 weeks. Participants in the exercise arm significantly increased exercise vs. controls (increase of 203 vs. 23 min/wk, p Conclusions: A pre-operative exercise intervention led to alterations in gene expression in tumor tissue in women with breast cancer. Validation in additional data sets and an analysis of which cellular compartments within the tumor are responsible for the changes is needed. These findings demonstrate that exercise may have a direct effect on breast tumor tissue in humans, providing new insights into the biologic mechanisms through which exercise could lower the risk of developing and dying from breast cancer. Citation Format: Ligibel JA, Irwin M, Dillon D, Barry W, Giobbie-Hurder A, Frank E, Winer EP, McTiernan A, Cornwell M, Pun M, Brown M, Jeselsohn R. Impact of pre-operative exercise on breast cancer gene expression [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S5-05.

Abstract P5-11-02: Impact of pre-operative exercise and mind-body interventions on patient-reported outcomes in women with newly diagnosed breast cancer

Abstract: Background: Breast cancer diagnosis has a number of adverse psychological effects. The Pre-Operative Health and Body (PreHAB) Study tested the impact of exercise and mind-body interventions upon on mood, quality of life, and patient-reported outcomes in women with newly diagnosed breast cancer. Methods: Women with newly diagnosed Stage I-III breast cancer were enrolled through Dana-Farber Cancer Institute and Yale University breast cancer clinics prior to surgery. Participants were randomized 1:1 to an aerobic and strength-training exercise intervention, comprised of twice-weekly meetings with an exercise trainer and home based aerobic exercise, or to a self-directed mind-body relaxation intervention, comprised of a book and CD focused on relaxation and visualization. Participants engaged in the interventions between enrollment and surgery. The EORTC QLQ C-30, Hospital Anxiety and Depression Scale, and Perceived Stress Scale were collected at enrollment and prior to surgery. Results: 49 women were randomized (27 exercise and 22 control). Mean time between enrollment and surgery was 4.2 weeks. At baseline, patients reported moderate levels of anxiety, stress, insomnia, and lack of appetite, as well as diminished emotional and cognitive functioning (Table). Exercise participants significantly increased minutes of weekly exercise vs. mind-body participants (increase of 203 vs. 23 min/wk, p Conclusions: Women with newly diagnosed breast cancer reported a number of physical and psychological symptoms in the pre-operative period. Exercise and mind-body interventions demonstrated promising benefits in improving functioning and reducing symptoms. More work is needed to develop pre-operative programs to help reduce the distress imparted by a cancer diagnosis in the critical time between diagnosis and surgery. Table* *Results reported as means (SD). Positive scores on functional and QOL measures indicate improvements; negative scores on symptom measures indicate a decrease in symptoms. Citation Format: Ligibel JA, Giobbie-Hurder A, Dillion D, Shockro L, Campbell N, Rhei E, Troyan S, Dominici L, Golshan M, Chagpar A, Yung R, Freedman R, Tolaney S, Winer E, Frank E, McTiernan A, Irwin M. Impact of pre-operative exercise and mind-body interventions on patient-reported outcomes in women with newly diagnosed breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-11-02.

Multicenter, randomized phase II trial of physical activity (PA), metformin (Met), or the combination on metabolic biomarkers in stage I-III colorectal (CRC) and breast cancer (BC) survivors.

Abstract: 10059Background: Observational data demonstrate an inverse relationship between PA and Met to disease outcomes in CRC & BC pts. A mechanism that these could impact cancer recurrence and mortality i...