Clinical Trials Directory

Trials / Completed

CompletedNCT05631587

A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Cancer survivors generally have low physical activity (PA) levels. While literature shows some evidence of improvement in PA following technology-based PA promotion interventions among cancer survivors, high-quality randomised control trials (RCTs), with objective measures of PA and longer-term follow-up, are lacking. Using a theoretical framework that addresses action control in addition to intention formation may enhance intervention effect. The Multi-process action control (M-PAC) framework is an extension of the traditional intention-formation theories, incorporating constructs that address the translation of intention into behaviour and continual action control. After comprehensively searching, no previous or ongoing RCTs have investigated the efficacy of a technology-based PA promotion intervention in cancer survivors that is designed based on the M-PAC framework. Investigators therefore propose a RCT to evaluate a technology-based intervention (WExercise) to support the promotion of PA in cancer survivors.

Detailed description

Objective: To develop a technology-based physical activity promotion intervention (WExercise) for cancer survivors based on the Multi-process Action Control (M-PAC) Framework and examine its usability and efficacy. Main hypothesis: The WExercise group will have a significantly greater increase in aerobic exercise than the self-directed exercise group at post-intervention. Design: Phase 1- Application development; Phase 2- Usability testing (n=10); Phase 3- Assessor-blind two-arm randomized controlled trial (n=98; WExercise or self-directed exercise group). Subjects: Physically inactive cancer survivors who have completed curative treatment. Study instruments: Accelerometry, Godin Leisure Time Exercise Questionnaire, 6-minute walk test, EORTC QLQ-C30, M-PAC questionniare; administered at baseline, post-intervention, and 3 months post-intervention. Interventions: Both groups will receive written physical activity guidelines with a goal to engage in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise per week. The WExercise group will additionally receive 10 weekly automated online classes delivered on a mobile application which aim at developing participants' reflective, regulatory, and reflexive processes based on the M-PAC to achieve recommended physical activity levels (1st-3rd week: intention formation; 4th-8th weeks: behavioral regulations; 9th-10th weeks: action control maintenance). Main outcomes: Time spent in moderate-to-vigorous aerobic exercise (primary), exercise capacity, and quality of life. Data analysis: Intention-to-treat analysis will be performed. Application usage in the WExercise group will be presented in descriptive statistics. Generalized linear mixed-effect models will be used to assess between-group and within-group differences in the outcomes. Expected results: The findings will inform the design of future eHealth interventions to encourage and sustain health behavior change in cancer survivors.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWExerciseA 10-weekly technology-based intervention delivered in a mobile application using the M-PAC framework to promote PA in post-treatment cancer survivors. Participants will be given individualised access to the app. Participants will be sent reminders (3 days apart) by WhatsApp/WeChat each time they have a class due.
BEHAVIORALControlA control group receiving an information sheet for self-directed exercise.

Timeline

Start date
2022-12-01
Primary completion
2024-05-31
Completion
2024-05-31
First posted
2022-11-30
Last updated
2025-05-28

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT05631587. Inclusion in this directory is not an endorsement.