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

NCT ID: NCT05631587

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-05-31

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.

Conditions

Cancer; Survivorship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention condition (WExercise)

Participants will receive a written information sheet (i.e., PA guide, safety precautions, and goal) same as the control group. In addition, participants in the WExercise group will be provided with 10 weekly technology-based classes delivered in a mobile application aimed at promoting PA. Participants will be given individualised access to the app. The classes aim at developing reflective, regulatory, and reflexive processes of cancer survivors to engage in PA based on the M-PAC framework. Participants will be sent reminders (3 days apart) by WhatsApp/WeChat each time they have a class due.

Group Type: EXPERIMENTAL

WExercise

Intervention Type: BEHAVIORAL

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 condition (Self-directed exercise)

Participants will receive a one-page written information sheet regarding the PA guidelines for cancer survivors and exercise safety precautions extracted from the website of the Centre for Health Protection of the HKSAR Government. Although mixed aerobic and resistance exercise are recommended, participants will be provided with a simple goal of increasing their aerobic exercise levels to 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic exercise per week because resistance exercise requires instructions from trained personnel.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

A control group receiving an information sheet for self-directed exercise.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

A control group receiving an information sheet for self-directed exercise.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Victoria

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Cheung Shuk-Ting

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 6290280 (View on PubMed)

Other Identifiers

UW 21485

Identifier Type: -

Identifier Source: org_study_id