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Background Direct-to-consumer mHealth devices are a potential asset to behavioral research but are rarely tested as intervention tools. This trial examined the accelerometer-based Fitbit tracker and website as a basis for a low-touch physical activity intervention. Purpose To evaluate, within a randomized controlled trial, the feasibility and preliminary efficacy of integrating the Fitbit tracker and website into a physical activity intervention for postmenopausal women. Methods Fifty-one inactive, postmenopausal women with BMI≥25.0 kg/m2 were randomized to a 16-week web-based self-monitoring intervention (N=25) or a comparison group (N=26). Those in the Web-Based Tracking Group received a Fitbit, an instructional session, and a follow-up call at 4 weeks. The comparison group received a standard pedometer. All were asked to perform 150 min/week of moderate-to-vigorous physical activity (MVPA). Physical activity outcomes were measured by the ActiGraph GT3X+ accelerometer. Results Data were collected and analyzed in 2013–2014. Participants were 60±7 years old with BMI=29.2±3.5 kg/m2. Relative to baseline, the Web-Based Tracking Group increased MVPA by 62±108 min/week (p<.01), MVPA in 10-min bouts by 38±83 min/week (p=.008), and steps by 789±1,979 (p=.01), compared to non-significant increases in the Pedometer Group (between-group p-values: .11, .28 and .30, respectively). The Web-Based Tracking Group wore the tracker on 95% of intervention days; 96% reported liking the website and 100% liked the tracker. Conclusions The Fitbit was well-accepted in this sample of women and was associated with increased physical activity at 16 weeks. By leveraging direct-to-consumer mHealth technologies that align with behavior change theories, researchers can strengthen physical activity interventions.

BACKGROUND Older women with breast cancer are underrepresented in clinical trials, and data on the effects of adjuvant chemotherapy in such patients are scant. We tested for the noninferiority of capecitabine as compared with standard chemotherapy in women with breast cancer who were 65 years of age or older. METHODS We randomly assigned patients with stage I, II, IIIA, or IIIB breast cancer to standard chemotherapy (either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin) or capecitabine. Endocrine therapy was recommended after chemotherapy in patients with hormone-receptor–positive tumors. A Bayesian statistical design was used with a range in sample size from 600 to 1800 patients. The primary end point was relapse-free survival. RESULTS When the 600th patient was enrolled, the probability that, with longer follow-up, capecitabine therapy was highly likely to be inferior to standard chemotherapy met a prescribed level, and enrollment was discontinued. After an additional year of follow-up, the hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 to 3.17; P<0.001). Patients who were randomly assigned to capecitabine were twice as likely to have a relapse and almost twice as likely to die as patients who were randomly assigned to standard chemotherapy (P = 0.02). At 3 years, the rate of relapse-free survival was 68% in the capecitabine group versus 85% in the standard-chemotherapy group, and the overall survival rate was 86% versus 91%. Two patients in the capecitabine group died of treatment-related complications; as compared with patients receiving capecitabine, twice as many patients receiving standard chemotherapy had moderate-to-severe toxic effects (64% vs. 33%). CONCLUSIONS Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. (ClinicalTrials.gov number, NCT00024102.)

A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables-fruits and moderate levels of physical activity. The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival.