Improving physical activity in men with prostate cancer through wearable devices and online education: Randomized controlled trial.

Neither the consent rate nor the retention rate met pre-specified feasibility targets in this pilot RCT.

• Consent rate was 12.1% (28/231 contacted), which did not meet feasibility targets.
• Retention rate was 52.4% (11/21 enrolled), which also did not meet feasibility targets.
• Twenty-one participants were ultimately recruited, with a mean age of 67 years (SD 8.7) and 52.4% were mainly retired.
• Despite low consent and retention, participants found the study acceptable.

Moderate intervention adherence was achieved among participants who remained in the study.

• Adherence was reported as 3/5 (60%), characterized as moderate.
• Feasibility metrics assessed included consent rate, retention rate, adherence, and study acceptability.
• Participants who remained in the study found it acceptable despite recruitment and retention challenges.

Wearable device (WEAR) use showed a trend toward reduced cancer-related fatigue exceeding the Minimal Clinically Important Difference, while online education (EDU) alone did not.

• Average effect across time points for fatigue (FACT-F) was 3.8 (95% CI -5.4, 12.9) for the WEAR condition.
• Average effect for fatigue (FACT-F) was -1.1 (95% CI -10.4, 8.3) for the EDU condition.
• The Minimal Clinically Important Difference (MCID) for FACT-F is 3 points.
• The WEAR group's mean effect of 3.8 exceeded the MCID, though confidence intervals were wide.
• A constrained longitudinal data analysis was used for efficacy outcomes.

Wearable device use showed a trend toward reduced sedentary behaviour exceeding the Minimal Clinically Important Difference, while online education alone showed a negative trend.

• Effect on sedentary behaviour (Sit-Q-7d) was 2.3 (95% CI -2.8, 7.4) for the WEAR condition.
• Effect on sedentary behaviour (Sit-Q-7d) was -1.0 (95% CI -5.7, 3.7) for the EDU condition.
• The MCID for Sit-Q-7d is 1.9 hours.
• The WEAR group's mean effect of 2.3 exceeded the MCID, though confidence intervals were wide and crossed zero.
• Sedentary behaviour was assessed using both the Sit-Q-7d questionnaire and accelerometry.

The study employed a 2x2 factorial randomized controlled trial design targeting sedentary adult men with prostate cancer using technology-based interventions.

• Participants were randomized to one of four arms: WEAR only, EDU only, WEAR + EDU, and control.
• Eligibility criteria included adult males with prostate cancer, currently sedentary (less than 150 minutes per week of activity), fluent in English, and having a computer with internet access.
• Assessments included FACT-F, FACT-G, Sit-Q-7d, accelerometry, and Patient Health Questionnaire (PHQ-9).
• Descriptive statistics were used for feasibility outcomes and constrained longitudinal data analysis for efficacy outcomes.

The study was not large enough to precisely estimate treatment effects, limiting conclusions about the efficacy of the interventions.

• Only 21 participants were recruited, far below what would be needed for definitive efficacy conclusions.
• Wide confidence intervals for all primary outcomes reflect this underpowering.
• The authors noted that 'the study was not large enough to precisely estimate treatment effects.'
• Future studies were recommended to use strategies to increase recruitment and retention.