Irwin ML, Cadmus L, Alvarez-Reeves M, O'Neil M, Mierzejewski E, Latka R, et al. Recruiting and retaining breast cancer survivors into a randomized controlled exercise trial: the Yale Exercise and Survivorship Study

Department of Epidemiology and Public Health, Yale School of Medicine, New Haven, Connecticut, USA.
Cancer (Impact Factor: 4.89). 06/2008; 112(11 Suppl):2593-606. DOI: 10.1002/cncr.23446
Source: PubMed


Given observational findings that physical activity reduces breast cancer risk, improves survival, and improves quality of life in breast cancer survivors, a need has been identified for randomized controlled trials that test the efficacy of exercise on biological mechanisms associated with breast cancer survival. The primary aims of the Yale Exercise and Survivorship Study were to 1) determine the feasibility of recruiting breast cancer survivors into a randomized controlled trial of the effects of exercise on biological markers and/or mechanisms associated with survival, 2) compare the effectiveness of various recruitment strategies on accrual rates and baseline characteristics, and 3) report adherence to the exercise trial.
Seventy-five postmenopausal breast cancer survivors self-referred into the trial or were recruited through the New Haven Tumor [corrected] Registry and randomly assigned to an exercise (n = 37) or usual-care (n = 38) group. The exercise group participated in 150 min/wk of supervised gym-based and home-based aerobic exercise for 6 months. The usual-care group was instructed to maintain current physical activity level.
A total of 75 women (an accrual rate of 9.5%) were randomized to the trial. Rates of accrual were higher for women who self-referred into the study (19.8%) compared with women recruited via the cancer registry (7.6%); however, demographic, physiologic, and prognostic characteristics did not differ between the 2 recruitment strategies. On average, exercisers increased moderate- intensity to vigorous-intensity aerobic exercise by 129 minutes per week compared with 44 minutes per week among usual-care participants (P < .001). Women in the exercise-intervention group increased their average pedometer steps by 1621 steps per day compared with a decrease of 60 steps per day among women in the usual-care group (P < .01).
Findings from this study will provide useful information for investigators who are conducting exercise trials in cancer populations, clinicians who are treating women diagnosed with breast cancer, and exercise professionals who are developing community-based exercise programs for cancer survivors.

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    • "Five studies [31, 32, 37–39] offered group exercise options and alternatives to walking in their intervention design. For example, Irwin (2008) reported that, in the home-based portion of the study, participants were asked to walk or do another aerobic activity of their choice. Bloom (2008) offered three group workshops, of which group exercise (Qigong, yoga or walking) was a part. "
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    ABSTRACT: Research has shown that recent post-treatment breast cancer survivors face significant challenges around physical activity as they transition to recovery. This review examined randomized controlled trials targeting physical activity behavior change in breast cancer survivors <5 years post-treatment and described (1) characteristics of interventions for breast cancer survivors as well as (2) effect size estimates for these studies. A systematic search was conducted following PRISMA guidelines with Medline, PubMed, PsycINFO, CINAHL, and Scopus databases. Data were abstracted for primary intervention strategies and other details (e.g., setting, duration, theory use). A subgroup analysis was conducted to assess intensity of exercise supervision/monitoring and intervention effectiveness. The search produced 14 unique behavior intervention trials from the US and abroad published 2005-2013. The mean sample size was 153 participants per study. All interventions included moderate-intensity activities plus various behavioral change strategies. Most interventions were partially or entirely home based. The overall standardized mean difference was 0.47 (0.23, 0.67) with p < 0.001. Most interventions were effective in producing short-term behavior changes in physical activity, but varied greatly relative to intervention strategies and intensity of supervision/monitoring. Highly structured interventions tended to produce larger behavior change effects overall, but many larger effect sizes came from interventions supported by phone counseling or e-mail. We observed that 'more' may not be better in terms of direct supervision/monitoring in physical activity behavior interventions. This may be important in exploring less resource-intensive options for effective behavior change strategies for recent post-treatment survivors.
    Breast Cancer Research and Treatment 01/2015; 149(2). DOI:10.1007/s10549-014-3255-5 · 3.94 Impact Factor
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    • "A unique component of this study is the inclusion of a 12-week follow-up period of the Exercise group after completion of the trial to measure longer-term adherence. Numerous cancer-related exercise interventions have failed to examine whether the benefits of the intervention persist following study completion despite reporting high (>80%) adherence rates [83,84]. This is an important aspect to investigate mainly since the benefits of exercise diminish due to failure of the participants to maintain a regular exercise program following study completion. "
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    ABSTRACT: Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments.Methods/design: This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis.Trial registration: NCT01140282; Registration: June 10, 2010.
    BMC Cancer 04/2014; 14(1):238. DOI:10.1186/1471-2407-14-238 · 3.36 Impact Factor
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    • "At baseline and 6 months, participants completed an interview-administered physical activity questionnaire, which was used to assess the past 6 months of recreational activity [17] and a seven-day physical activity log [18]. Women recorded the type and duration of any physical activity done on each day for the physical activity log. "
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    ABSTRACT: Objective. Breast cancer survivors are highly sedentary, overweight, or obese, which puts them at increased risk for comorbid chronic disease. We examined the prevalence of, and changes in, metabolic syndrome following 6 months of an aerobic exercise versus usual care intervention in a sample of sedentary postmenopausal breast cancer survivors. Design and Methods. 65 participants were randomized to an aerobic exercise intervention (EX) (n = 35) mean BMI 30.8 (±5.9) kg/m(2) or usual care (UC) (n = 30) mean BMI 29.4 (±7.4) kg/m(2). Metabolic syndrome prevalence was determined, as well as change in criteria and overall metabolic syndrome. Results. At baseline, 55.4% of total women met the criteria for metabolic syndrome. There was no statistically significant change in metabolic syndrome when comparing EX and UC. However, adhering to the exercise intervention (at least 120 mins/week of exercise) resulted in a significant (P = .009) decrease in metabolic syndrome z-score from baseline to 6 months (-0.76 ± 0.36) when compared to those who did not adhere (0.80 ± 0.42). Conclusions. Due to a higher prevalence of metabolic syndrome in breast cancer survivors, lifestyle interventions are needed to prevent chronic diseases associated with obesity. Increasing exercise adherence is a necessary target for further research in obese breast cancer survivors.
    International Journal of Endocrinology 11/2013; 2013(3):168797. DOI:10.1155/2013/168797 · 1.95 Impact Factor
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