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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631587
• Other study ID #: UW 21485
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Denise Cheung, PhD
• Phone: 3917 6673
• Email: denisest[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Survivorship

Intervention

Behavioral:
• WExercise
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.
• Control
A control group receiving an information sheet for self-directed exercise.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	University of Victoria

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Liu S, Husband C, La H, Juba M, Loucks R, Harrison A, Rhodes RE. Development of a self-guided web-based intervention to promote physical activity using the multi-process action control framework. Internet Interv. 2018 Dec 4;15:35-42. doi: 10.1016/j.invent.2018.11.003. eCollection 2019 Mar. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aerobic exercise behaviour (objective measure)	Measured as time spent in moderate-to-vigorous aerobic exercise using accelerometer	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.
Primary	Change in aerobic exercise behaviour (subjective measure)	Measured by the Godin Leisure Time Exercise Questionnaire (Min and Max NA; higher scores represent higher aerobic exercise level)	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	Change in exercise capacity	Measured by the 6-minute walk test to estimate the peak oxygen uptake	Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
Secondary	Change in cancer-specific Quality of life	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.	Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
Secondary	Change in key components of M-PAC framework	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.	Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).
Secondary	Application usage	Reported as the number of interventional classes completed using inbuilt tracking tools.	Measure at post-intervention (Week 11)