NCT05631587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

November 7, 2022

Last Update Submit

May 26, 2025

Conditions

Keywords

cancer survivorphysical activitywebsite

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Change in exercise capacity

    Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).

  • Change in cancer-specific Quality of life

    Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).

  • Change in key components of M-PAC framework

    Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).

  • Application usage

    Measure at post-intervention (Week 11)

Study Arms (2)

Intervention condition (WExercise)

EXPERIMENTAL

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.

Behavioral: WExercise

Control condition (Self-directed exercise)

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

WExerciseBEHAVIORAL

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 condition (WExercise)
ControlBEHAVIORAL

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

Control condition (Self-directed exercise)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • have a psychiatric disorder
  • significant cognitive impairment
  • a history of more than one cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    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.

    PMID: 6290280BACKGROUND

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Denise Cheung, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A two-arm, assessor-blinded RCT examining the effect of a website for physical activity promotion in cancer survivors (WExercise)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 30, 2022

Study Start

December 1, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations