APPROACH: pilot trial - version 1
Research type
Research Study
Full title
APPROACH: an app for health & wellbeing after cancer – a pilot randomised controlled trial
IRAS ID
235354
Contact name
Abigail Fisher
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN18063498
Clinicaltrials.gov Identifier
UCL Data Protection Registration number, Z6364106 2020 10 29
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The primary research objective is to assess the feasibility and acceptability of carrying out a randomised controlled trial (RCT) of a physical activity intervention delivered via smartphone app (with behavioural support) in people affected by breast, prostate or colorectal cancer.
This pilot RCT has two arms; the physical activity intervention and a usual care control arm. Eligible participants will be randomised to one of these two groups (45 per arm). Participants will complete study assessments at baseline and 12-week follow-up. Study assessments include objective measures of physical activity (measured with an accelerometer) and questionnaire assessments of self-reported physical activity, health-related quality of life, cancer-specific quality of life, fatigue, sleep, anxiety and depression, physical activity self-efficacy (confidence), self-efficacy for self-management of cancer, habit strength for walking and health and social care service use. Height, weight and waist circumference will also be measured by a researcher at baseline (where possible), and self-reported at 12-week follow-up. Sociodemographic and disease characteristics will also be asked at baseline only. Semi-structured interviews with up to 20 control and 30 intervention participants will be conducted to understand experiences of participating in the trial and being randomised. Reasons for declining will be sought from eligible participants who choose not to participate if they are willing to share. A further 30 semi-structured interviews will also be conducted with those who decline participation in the study to gain more detailed insight into why this might be.
Participants randomised to the intervention arm will receive a leaflet about physical activity and cancer, and guidance about how to download the app being recommended to participants (promoting brisk walking). Intervention participants will also receive two behavioural support telephone/video calls, focusing on how participants may use the app to increase brisk walking and resolving any problems downloading the app.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0029
Date of REC Opinion
23 Mar 2021
REC opinion
Further Information Favourable Opinion