A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- The University of Hong Kong
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change in aerobic exercise behaviour (subjective measure)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •≥18 years of age
- •completion of primary treatment (surgery/chemo-/radiation therapy) of curative intent for at least 12 months,
- •no metastasis, no recurrence
- •not meeting the recommended PA guideline (\<150 min of moderate intensity aerobic exercise and \<75 min of vigorous aerobic exercise per week)
- •access to Internet
- •able to read Chinese and communicate in Cantonese or Putonghua
- •screened by a nurse as no contraindications for engaging in unsupervised exercise using a risk screening tool
Exclusion Criteria
- •have a psychiatric disorder
- •significant cognitive impairment
- •a history of more than one cancer
Outcomes
Primary Outcomes
Change in aerobic exercise behaviour (subjective measure)
Time Frame: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). Self-reported minutes of moderate-to-vigorous aerobic exercise will be recorded.
Measured by the Godin Leisure Time Exercise Questionnaire (Min and Max NA; higher scores represent higher aerobic exercise level)
Change in aerobic exercise behaviour (objective measure)
Time Frame: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). Each time point will measure 7 full consecutive days and average time (minutes) per day spent in moderate-to-vigorous aerobic exercise will be reported.
Measured as time spent in moderate-to-vigorous aerobic exercise using accelerometer
Secondary Outcomes
- Change in exercise capacity(Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Change in key components of M-PAC framework(Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Change in cancer-specific Quality of life(Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Application usage(Measure at post-intervention (Week 11))