- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631587
A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denise Cheung, PhD
- Phone Number: 3917 6673
- Email: denisest@hku.hk
Study Contact Backup
- Name: Tiffany Kwok, MPH
- Email: tiffkwok@connect.hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
-
Contact:
- Shuk Ting Cheung, PhD
- Phone Number: 39176673
- Email: denisest@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
A control group receiving an information sheet for self-directed exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in aerobic exercise behaviour (objective measure)
Time Frame: 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
|
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.
|
Change in aerobic exercise behaviour (subjective measure)
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in exercise capacity
Time Frame: 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
|
Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
|
Change in cancer-specific Quality of life
Time Frame: 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.
|
Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).
|
Change in key components of M-PAC framework
Time Frame: 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.
|
Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).
|
Application usage
Time Frame: Measure at post-intervention (Week 11)
|
Reported as the number of interventional classes completed using inbuilt tracking tools.
|
Measure at post-intervention (Week 11)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Denise Cheung, PhD, The University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UW 21485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States