Journal Article

An App-Based Behavioral Support Intervention Promoting Physical Activity (APPROACH) in Patients Diagnosed With Breast, Prostate, or Colorectal Cancer: Protocol for a Randomized Controlled Trial

Smith, Lee, Counsell, Nicholas, Greenfield, Diana M, Lally, Phillippa, Wyld, Lynda, Kennedy, Fiona, Truscott, Hannah, Roberts, Anna, Beeken, Rebecca J, Potts, Henry WW, Latimer, Nicholas, Fisher, Abigail, Smith, Sue L, Stevens, Rosie, Gath, Jacqui, Buck, Caroline, Shearsmith, Leanne, Lowther, Ed, Creaser, Amy, Thomas, Chloe

2026

Overview

Strong evidence highlights that sufficient physical activity (PA) has multiple benefits for people living with and beyond cancer. However, many are not meeting PA recommendations. APPROACH is a trial of a theory-driven, app-based behavioral support intervention to promote brisk walking after breast, prostate, or colorectal cancer. The aim of this trial is to evaluate the efficacy and cost-effectiveness of the intervention. APPROACH is a multicenter, phase III, 2-armed, individually randomized controlled trial (N=472). We will recruit patients with localized breast, prostate, or colorectal cancer from hospitals in Yorkshire and surrounding areas in the North of England, United Kingdom, and randomize them 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 behavioral support, including 2 brief telephone or 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) after 3 months. Demographic and medical characteristics will be collected through self-report and hospital records. Secondary outcomes (assessed at 0, 3, and 6 months) will be the other activPAL-assessed outcomes (brisk walking at 6 months, total steps, light PA, standing time, and sitting times, weekly metabolic equivalent of task), self-reported PA, and self-reported BMI 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. We will use health economic modeling to estimate the cost-effectiveness of the intervention over a lifetime horizon. The study was funded in June 2019. Trial recruitment commenced in November 2023 and is planned to be completed in 2025. As of December 2025, a total of 473 participants have been randomized. The publication of the main results is expected in autumn 2027 after all follow-up data collection and analysis are complete. 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 PA among people living with and beyond cancer. ISRCTN Registry ISRCTN14149329; https://www.isrctn.com/ISRCTN14149329. DERR1-10.2196/77096.

• Publisher: JMIR Publications,JMIR Publications Inc
• Subject: Aged / Behavior / Behavior Therapy - methods / Breast Neoplasms - psychology / Breast Neoplasms - therapy / Clinical trials / Colorectal cancer / Colorectal Neoplasms - psychology / Colorectal Neoplasms - therapy / Cost analysis / Cost-Benefit Analysis / Exercise / Exercise - psychology / Female / Health Promotion - methods / Humans / Intervention / Male / Medical diagnosis / Medical research / Middle Aged / Mobile Applications / Multicenter Studies as Topic / Oncology / Physical fitness / Pilot projects / Prostate / Prostatic Neoplasms - psychology / Prostatic Neoplasms - therapy / Protocol / Qualitative research / Quality of Life / Randomized Controlled Trials as Topic / Smartphones / Walking