To hear about similar clinical trials, please enter your email below
Trial Title:
A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
NCT ID:
NCT05631587
Condition:
Cancer
Survivorship
Conditions: Keywords:
cancer survivor
physical activity
website
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A two-arm, assessor-blinded RCT
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
WExercise
Description:
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.
Arm group label:
Intervention condition (WExercise)
Intervention type:
Behavioral
Intervention name:
Control
Description:
A control group receiving an information sheet for self-directed exercise.
Arm group label:
Control condition (Self-directed exercise)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Shuk Ting Cheung, PhD
Phone:
39176673
Email:
denisest@hku.hk
Start date:
November 1, 2022
Completion date:
April 2024
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
University of Victoria
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05631587
