Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 7, 2025
Open Peer Review Period: May 7, 2025 - Jul 2, 2025
Date Accepted: Nov 29, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
An app-based behavioural support intervention promoting physical activity (APPROACH) in patients diagnosed with breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial
ABSTRACT
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, 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. The final analysis is planned for 2026 after all data collection is complete.
Conclusions:
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. Clinical Trial: ISRCTN registry, ISRCTN14149329 https://doi.org/10.1186/ISRCTN14149329. Registered 11 September 2023.
Citation
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Copyright
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