Clinical trial NCT05631587: A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
Official title: A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Survivorship
Keywords: cancer survivor
physical activity
website
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University of Victoria
First posted: 2022-11-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm, assessor-blinded RCT examining the effect of a website for physical activity promotion in cancer survivors (WExercise)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in aerobic exercise behaviour (objective measure)
timeFrame: 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.
measure: Change in aerobic exercise behaviour (subjective measure)
timeFrame: 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.
Secondary outcomes:
measure: Change in exercise capacity
timeFrame: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
measure: Change in cancer-specific Quality of life
timeFrame: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
measure: Change in key components of M-PAC framework
timeFrame: Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).
measure: Application usage
timeFrame: Measure at post-intervention (Week 11)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Denise Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes RE. Chapter Five - The Evolving Understanding of Physical Activity Behavior: A Multi-Process Action Control Approach. In: Elliot AJ, editor. Advances in Motivation Science. 4: Elsevier; 2017. p. 171-205.
citation: Gutteridge JM, Toeg D. Iron-dependent free radical damage to DNA and deoxyribose. Separation of TBA-reactive intermediates. Int J Biochem. 1982;14(10):891-3. doi: 10.1016/0020-711x(82)90071-4.