Background

Strong evidence highlights that sufficient physical activity has multiple benefits for people living with and beyond cancer. However, many are not meeting physical activity recommendations.APPROACH is a trial of a theory-driven, app-based behavioural support intervention to promote brisk walking after breast, prostate or colorectal cancer. 

Objective

The aim of the current trial is to evaluate the efficacy and cost-effectiveness of the intervention.

Methods

APPROACH is a multicentre, Phase III, two-armed, individually randomised controlled trial (N=472). Patients with localised breast, prostate, or colorectal cancer will be recruited from hospitals in Yorkshire and surrounding areas in the North of England, UK, and randomised 1:1 between the intervention and control arm (usual care). The intervention consists of an app designed for the general population to encourage brisk walking (NHS Active 10), supplemented with habit-based behavioural support including two brief telephone/video calls, a leaflet, website, and walking planners. The primary endpoint is the difference between trial arms in the changes from baseline in activPAL-assessed average minutes of brisk walking (≥100 steps per minute, spm) after 3 months. 

Demographic and medical characteristics will be collected, through self-report and hospital records. Secondary outcomes (assessed at 0, 3, 6 months) will be the other activPAL-assessed outcomes (brisk walking at 6 months, total steps, light physical activity, standing time and sitting times, weekly metabolic equivalent of task), self-reported physical activity, and self-reported body mass index and waist circumference. Patient-reported outcome measures of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, habit strength for walking, and social support will also be collected. Interviews will explore experiences of receiving the intervention. Health economic modelling will estimate cost-effectiveness of the intervention over a lifetime horizon.

Results

Trial recruitment commenced in November 2023 and is planned to complete in 2025. To date N=469 participants have been randomised. The final analysis is planned for 2026/2027 after all follow-up data collection is complete.

Discussion

Overall findings will determine the clinical and cost-effectiveness of the intervention for patients diagnosed with breast, prostate or colorectal cancer. If successful, APPROACH provides a potential model of supportive care to increase physical activity among people living with and beyond cancer.

Trial registration

ISRCTN registry, ISRCTN14149329 https://doi.org/10.1186/ISRCTN14149329. Registered 11 September 2023.