Platinum Priority – Prostate CancerEditorial by Camille E. Short, Linda Trinh and Erica L. James on pp. 959–960 of this issueFeasibility, Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer
Introduction
Recent observational studies and preclinical evidence suggest that certain lifestyle behaviors may reduce the risk of prostate cancer progression [1]. Lifestyle factors that have been associated with improved clinical outcomes (ie, reduced prostate cancer mortality, metastasis, prostate-specific antigen progression, and initiation of secondary treatments) in men with prostate cancer include vigorous physical activity [2]; brisk walking [3]; not smoking [4], [5]; higher intake of vegetable fat [6], cruciferous vegetables [7], tomato sauce [8], and fish [8], [9]; and lower intake of processed meat [10], [11] and supplemental selenium [12]. Many of these lifestyle factors also reduce the risk of cardiovascular outcomes, the leading cause of death worldwide.
Digital interventions targeting these behaviors can minimize expense and time required for phone or in-person counseling, reduce cost and burden associated with participation in on-site interventions, and scale up more readily and cost effectively for maximum reach compared with other designs. Digital interventions are promising for improving physical activity and body mass index (BMI) among cancer survivors, with mixed evidence for diet, but no studies conducted specifically for prostate cancer were found [13]. Digital health interventions have been pilot tested and shown to be effective in women with breast cancer at increasing moderate-intensity aerobic exercise and fruit and vegetable consumption over 12 wk [14], and in women at an increased risk for breast cancer at losing weight and increasing physical activity over 12 wk [15].
Therefore, we created and piloted a remote, technology enhanced lifestyle intervention for men with prostate cancer. A 12-wk pilot randomized controlled trial (RCT), Prostate 8 (NCT02470936), was conducted to determine study feasibility, acceptability, and preliminary efficacy of a digital health intervention on lifestyle behaviors. We further explored the intervention's impact on health-related quality of life (QOL), biomarkers, and body size after 12 wk and behaviors after 1 yr.
Section snippets
Study design, recruitment, and eligibility
Men were randomized 1:1 to the lifestyle program or the control arm. We based our sample size on study feasibility (using an adherence measure) and behavior change. The lifestyle program included a text message component, and adherence was defined as responding to a text message each week. Our expected adherence rate was 70% (95% confidence interval [CI]: 50%, 84%). If the observed adherence rate was <50% (<16 participants responded to text messages at least weekly), the intervention would not
Results
From June 5, 2015, to March 1, 2017, 76 men (mean age: 65 yr, range: 51–79 yr) were randomized to intervention (n = 37) and control (n = 39) arms. A total of 228 patients were assessed; 33% (n = 76) of them were randomized (Fig. 1). Of those excluded, 24.8% were already meeting more than four of the eight study recommendations, and 28% were unwilling to travel to UCSF for the baseline and 12-wk study visits. Four patients did not receive the allocated intervention (three in the intervention arm and one
Discussion
In this pilot RCT, we tested a lifestyle intervention utilizing a website, Fitbit, and text messages. Fitbit use and text message responsiveness were high, and website use was low. Satisfaction with these components ranged from 60% to 91%. Intervention participants reported greater changes in certain dietary behaviors than control participants at 12 wk. The intervention did not increase objective moderate or vigorous activity by accelerometer, although we observed a 1212-step (mean) increase by
Conclusions
In conclusion, a digital health lifestyle intervention was feasible and acceptable among men with prostate cancer, and preliminary data suggest that such an intervention may support at least short-term adoption of healthy diet behaviors. This work provides direction and rationale for future studies focused on biological and clinical endpoints to determine whether lifestyle change after prostate cancer reduces the risk of recurrence and mortality.
Author contributions: Stacey A. Kenfield had full
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