Cancer, Survivorship
Conditions
Keywords
cancer survivor, physical activity, website
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.
Interventions
BEHAVIORALWExercise
A 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.
BEHAVIORALControl
A control group receiving an information sheet for self-directed exercise.
Sponsors
University of Victoria
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A two-arm, assessor-blinded RCT examining the effect of a website for physical activity promotion in cancer survivors (WExercise)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aerobic exercise behaviour (objective measure) | 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 |
| Change in aerobic exercise behaviour (subjective measure) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). | Measured by the 6-minute walk test to estimate the peak oxygen uptake |
| Change in cancer-specific Quality of life | Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). | Measured by the 30-item European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) to estimate the general well-being of cancer patients. The score ranges from 0-100, a high score for a functional scale represents a healthy level of functioning; a high score for the global health status / QoL represents a high QoL; but a high score for a symptom scale / item represents more severe symptoms. |
| 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). | Measured by the Multi-Process Action Control (M-PAC) questionnaire. The following components will be measured in 5-point Likert scale: affective attitude (score:3-15), instrumental attitude(score:3-15), perceived capability (score:3-15), perceived opportunity (score:3-15), behavioural regulation (score:6-30), habit formation (score:4-20), identity formation (score:4-20); and two items for decisional intentions (score:1-12). Higher score means higher levels of reflective, regulatory, and reflexive processes that may have facilitated exercise behavior change. |
| Application usage | Measure at post-intervention (Week 11) | Reported as the number of interventional classes completed using inbuilt tracking tools. |
Countries
Hong Kong
Outcome results
None listed