NCT03859271

Brief Summary

This study aims to examine the efficacy of using Information Communication Technology (ICT) to deliver brief Motivational Interviewing (BMI) to promote regular physical activity among Hong Kong Chinese childhood cancer survivors.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

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

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

April 1, 2021

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

February 27, 2019

Last Update Submit

March 30, 2021

Conditions

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

  • Change in levels of physical activity from baseline to 12-month follow-up between intervention and control group

    The primary outcome measure is the physical activity levels of subjects at 12-month follow-up when compare to baseline. The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (CUHK-PARCY) will be used to assess participants' physical activity levels. It is a one-item scale, scores ranging from 0-2, 3-6 and 7-10 indicate low, moderate and high levels of physical activity respectively.

    12-month follow-up

Secondary Outcomes (24)

  • Levels of physical activity at baseline

    baseline

  • Change in levels of physical activity from baseline at 1-month follow-up between intervention and control group

    1-month follow-up

  • Change in levels of physical activity from baseline at 3-month follow-up between intervention and control group

    3-month follow-up

  • Change in levels of physical activity from baseline at 6-month follow-up between intervention and control group

    6-month follow-up

  • Levels of cancer-related fatigue at baseline

    Baseline

  • +19 more secondary outcomes

Study Arms (2)

brief motivational interviewing

EXPERIMENTAL

Participants will receive BMI and instant messaging delivered by a trained research nurse. At the time of recruitment, both children and parents will receive an education talk on the significance of and misconceptions about regular physical activity for cancer survivors and strategies for overcoming barriers to engaging in physical activity. Parents will then receive a face-to-face BMI to motivate their children to engage in regular physical activity. Parents will also be encouraged to motivate their children to intensify their physical activity levels progressively, with the ultimate goal of achieving the Global Recommendations on Physical Activity on Health suggested by the World Health Organization. Additionally, they will be invited to download a mobile health application from the Centre for Health Protection, Department of Health, HKSAR website that contains information on physical activity.

Behavioral: Brief motivational interviewing

Placebo Control

PLACEBO COMPARATOR

Children and parents will receive the education talk on physical activity and ask to download the mobile health application that contains information on physical activity at the time of recruitment similar to the intervention group. However, parents will not receive BMI and instant messaging throughout the study period.

Behavioral: Placebo control

Interventions

Children and parents will receive BMI and instant messaging delivered by a trained research nurse. At the time of recruitment, both children and parents will receive an education talk on the significance of and misconceptions about regular physical activity for cancer survivors and strategies for overcoming barriers to engaging in physical activity. Parents will then receive a face-to-face BMI to motivate their children to engage in regular physical activity. Parents will also be encouraged to motivate their children to intensify their physical activity levels progressively, with the ultimate goal of achieving the Global Recommendations on Physical Activity on Health suggested by the World Health Organization. Additionally, they will be invited to download a mobile health application from the Centre for Health Protection, Department of Health, HKSAR website that contains information on physical activity.

brief motivational interviewing
Placebo controlBEHAVIORAL

Children and parents will receive the education talk on physical activity and ask to download the mobile health application that contains information on physical activity at the time of recruitment similar to the intervention group. However, parents will not receive BMI and instant messaging throughout the study period.

Placebo Control

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 9 to 16 years;
  • Able to speak Cantonese and read Chinese;
  • Had completed cancer treatment at least six months previously; and
  • currently do not engage in regular physical exercise.

You may not qualify if:

  • The investigators will exclude childhood cancer survivors with evidence of recurrence or second malignancies, and those with physical impairment or cognitive and learning problems identified from their medical records.
  • Additionally, parents (either father or mother; the primary caregiver of childhood cancer survivors) must be able to:
  • Speak Cantonese and read Chinese,
  • Use a smartphone and can use an instant messaging tool (e.g., WhatsApp/WeChat); and
  • Are willing to receive health promotion advice and interact with our interventionist via WhatsApp/WeChat on a smartphone throughout the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Hong Kong

Hong Kong, China

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Cheung AT, Li WHC, Ho LLK, Chan GC, Lam HS, Chung JOK. Efficacy of Mobile Instant Messaging-Delivered Brief Motivational Interviewing for Parents to Promote Physical Activity in Pediatric Cancer Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214600. doi: 10.1001/jamanetworkopen.2022.14600.

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ho Cheung William Li

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

March 11, 2019

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

April 1, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations