がん患者における身体活動促進のためのアプリベース行動支援介入（APPROACH）の開発：ランダム化比較試験のプロトコル

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.