An app with brief behavioural support to promote physical activity after a cancer diagnosis (APPROACH): study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies

A. Roberts¹  P. Lally¹  A. Fisher¹  N. Miller¹  N. Counsell²  L. Wyld³  H. W. W. Potts⁴  F. Kennedy⁵  C. Martin⁵  R. J. Beeken⁵  N. Latimer⁶  C. Thomas⁶  D. M. Greenfield⁷  L. Smith⁸  J. Gath⁹ 

[1] Behavioural Science and Health, UCL;Cancer Research UK & UCL Cancer Trials Centre, Cancer Institute, University College London;Department of Oncology and Metabolism, University of Sheffield;Institute of Health Informatics, University College London;Leeds Institute of Health Sciences, University of Leeds;School of Health and Related Research, University of Sheffield;Sheffield Teaching Hospitals NHS FT, Weston Park Hospital;The Centre for Health, Performance, and Wellbeing, Anglia Ruskin University;Yorkshire and Humberside Consumer Research Panel;

关键词: Cancer;    Pilot;    RCT;    Brisk walking;    Physical activity;    App;   

DOI  :  10.1186/s40814-022-01028-w

来源: DOAJ

【 摘 要 】

Abstract Background There are multiple health benefits from participating in physical activity after a cancer diagnosis, but many people living with and beyond cancer (LWBC) are not meeting physical activity guidelines. App-based interventions offer a promising platform for intervention delivery. This trial aims to pilot a theory-driven, app-based intervention that promotes brisk walking among people living with and beyond cancer. The primary aim is to investigate the feasibility and acceptability of study procedures before conducting a larger randomised controlled trial (RCT). Methods This is an individually randomised, two-armed pilot RCT. Patients with localised or metastatic breast, prostate, or colorectal cancer, who are aged 16 years or over, will be recruited from a single hospital site in South Yorkshire in the UK. The intervention includes an app designed to encourage brisk walking (Active 10) supplemented with habit-based behavioural support in the form of two brief telephone/video calls, an information leaflet, and walking planners. The primary outcomes will be feasibility and acceptability of the study procedures. Demographic and medical characteristics will be collected at baseline, through self-report and hospital records. Secondary outcomes for the pilot (assessed at 0 and 3 months) will be accelerometer measured and self-reported physical activity, body mass index (BMI) and waist circumference, and patient-reported outcomes of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, and habit strength for walking. Qualitative interviews will explore experiences of participating or reasons for declining to participate. Parameters for the intended primary outcome measure (accelerometer measured average daily minutes of brisk walking (≥ 100 steps/min)) will inform a sample size calculation for the future RCT and a preliminary economic evaluation will be conducted. Discussion This pilot study will inform the design of a larger RCT to investigate the efficacy and cost-effectiveness of this intervention in people LWBC. Trial registration ISRCTN registry, ISRCTN18063498 . Registered 16 April 2021.

【 授权许可】

Unknown