- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03859271
Using Information Communication Technology to Deliver Brief Motivational Interviewing
Using Information Communication Technology to Deliver Brief Motivational Interviewing to Promote Regular Physical Activity Among Chinese Childhood Cancer Survivors: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A substantial body of evidence has indicated that improved childhood cancer survival has inevitably been accompanied by increased chronic physical problems and adverse psychological late-effects of cancer and its treatment. The frequently reported physiological and psychological sequelae included cancer-related fatigue, reduced muscle strength, decreases in functional capacity, activity intolerance, depression and distorted self-esteem, which in turn severely comprises their quality of life.
There is a growing body of evidence highlighting the beneficial effects of physical activity on the physiological and psychological health of childhood cancer survivors. Particularly, substantial evidence reveals that engaging in regular moderate-intensity physical activity can help ameliorate some of the treatment-related adverse effects experienced by childhood cancer survivors, such as reduce cancer-related fatigue, enhance muscle strength, improve cardiovascular fitness and eventually lead to a better quality of life.
Evidence demonstrates that education alone is insufficient or unlikely to change behavior. Motivational interviewing (MI) is a directive, client-centered counseling strategy which differs from prevailing patient education to support clients to explore and resolve their ambivalence about changing their behaviors. Meanwhile, there is an increase in the use of Information Communication Technology (ICT) for health care delivery and health promotion. Using instant messaging (i.e. WhatsApp or WeChat) allows quick, direct and continuing professional advice and support for the parents to promote their child's level of physical activity. Therefore, the aim of this study is to examine the efficacy of using ICT to deliver BMI to promote regular physical activity among Hong Kong Chinese childhood cancer survivors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The Inclusion Criteria for eligible Hong Kong Chinese childhood cancer survivals are as follows:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: brief motivational interviewing
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.
|
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.
|
|
Placebo Comparator: Placebo Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in levels of physical activity from baseline to 12-month follow-up between intervention and control group
Time Frame: 12-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levels of physical activity at baseline
Time Frame: 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.
|
baseline
|
|
Change in levels of physical activity from baseline at 1-month follow-up between intervention and control group
Time Frame: 1-month follow-up
|
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.
|
1-month follow-up
|
|
Change in levels of physical activity from baseline at 3-month follow-up between intervention and control group
Time Frame: 3-month follow-up
|
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.
|
3-month follow-up
|
|
Change in levels of physical activity from baseline at 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
|
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
|
6-month follow-up
|
|
Levels of cancer-related fatigue at baseline
Time Frame: Baseline
|
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
It contains 13 items, rated on a five-point Likert Scale, with scores ranging from 13 to 65.
Higher scores represent higher levels of cancer-related fatigue.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
It contains 12 items, evaluated on a five-point Likert Scale.
Scores range from 12 to 60, and higher scores indicate higher levels of fatigue.
|
Baseline
|
|
Change in levels of cancer-related fatigue from baseline at 1-month follow-up between intervention and control group
Time Frame: 1-month follow-up
|
he Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
It contains 13 items, rated on a five-point Likert Scale, with scores ranging from 13 to 65.
Higher scores represent higher levels of cancer-related fatigue.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
It contains 12 items, evaluated on a five-point Likert Scale.
Scores range from 12 to 60, and higher scores indicate higher levels of fatigue.
|
1-month follow-up
|
|
Change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group
Time Frame: 3-month follow-up
|
he Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
It contains 13 items, rated on a five-point Likert Scale, with scores ranging from 13 to 65.
Higher scores represent higher levels of cancer-related fatigue.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
It contains 12 items, evaluated on a five-point Likert Scale.
Scores range from 12 to 60, and higher scores indicate higher levels of fatigue.
|
3-month follow-up
|
|
Change in levels of cancer-related fatigue from baseline at 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
|
he Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
It contains 13 items, rated on a five-point Likert Scale, with scores ranging from 13 to 65.
Higher scores represent higher levels of cancer-related fatigue.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
It contains 12 items, evaluated on a five-point Likert Scale.
Scores range from 12 to 60, and higher scores indicate higher levels of fatigue.
|
6-month follow-up
|
|
Change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group
Time Frame: 12-month follow-up
|
he Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old.
It contains 13 items, rated on a five-point Likert Scale, with scores ranging from 13 to 65.
Higher scores represent higher levels of cancer-related fatigue.
For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
It contains 12 items, evaluated on a five-point Likert Scale.
Scores range from 12 to 60, and higher scores indicate higher levels of fatigue.
|
12-month follow-up
|
|
Muscle strength at baseline
Time Frame: Baseline
|
Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.
|
Baseline
|
|
Change in muscular strength from baseline at 1-month follow-up between intervention and control group
Time Frame: 1-month follow-up
|
Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.
|
1-month follow-up
|
|
Change in muscular strength from baseline at 3-month follow-up between intervention and control group
Time Frame: 3-month follow-up
|
Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.
|
3-month follow-up
|
|
Change in muscular strength from baseline at 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
|
Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.
|
6-month follow-up
|
|
Change in muscular strength from baseline at 12-month follow-up between intervention and control group
Time Frame: 12-month follow-up
|
Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.
|
12-month follow-up
|
|
Lung functionality at baseline
Time Frame: Baseline
|
A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.
|
Baseline
|
|
Change in lung functionality from baseline at 1-month follow-up between intervention and control group
Time Frame: 1-month follow-up
|
A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.
|
1-month follow-up
|
|
Change in lung functionality from baseline at 3-month follow-up between intervention and control group
Time Frame: 3-month follow-up
|
A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.
|
3-month follow-up
|
|
Change in lung functionality from baseline at 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
|
A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.
|
6-month follow-up
|
|
Change in lung functionality from baseline at 12-month follow-up between intervention and control group
Time Frame: 12-month follow-up
|
A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.
|
12-month follow-up
|
|
Quality of life at baseline
Time Frame: Baseline
|
The Chinese version of the Pediatric Quality of Life Inventory will be used to measure subjects' quality of life.
This scale has 23 items rated on a 5-point Likert scale.
These items are categorized into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items).
The range of possible scores is 0-100, with higher scores representing better quality of Life.
|
Baseline
|
|
Change in quality of life from baseline at 1-month follow-up between intervention and control group
Time Frame: 1-month follow-up
|
The Chinese version of the Pediatric Quality of Life Inventory will be used to measure subjects' quality of life.
This scale has 23 items rated on a 5-point Likert scale.
These items are categorized into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items).
The range of possible scores is 0-100, with higher scores representing better quality of Life.
|
1-month follow-up
|
|
Change in quality of life from baseline at 3-month follow-up between intervention and control group
Time Frame: 3-month follow-up
|
The Chinese version of the Pediatric Quality of Life Inventory will be used to measure subjects' quality of life.
This scale has 23 items rated on a 5-point Likert scale.
These items are categorized into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items).
The range of possible scores is 0-100, with higher scores representing better quality of Life.
|
3-month follow-up
|
|
Change in quality of life from baseline at 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
|
The Chinese version of the Pediatric Quality of Life Inventory will be used to measure subjects' quality of life.
This scale has 23 items rated on a 5-point Likert scale.
These items are categorized into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items).
The range of possible scores is 0-100, with higher scores representing better quality of Life.
|
6-month follow-up
|
|
Change in quality of life from baseline at 12-month follow-up between intervention and control group
Time Frame: 12-month follow-up
|
The Chinese version of the Pediatric Quality of Life Inventory will be used to measure subjects' quality of life.
This scale has 23 items rated on a 5-point Likert scale.
These items are categorized into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items).
The range of possible scores is 0-100, with higher scores representing better quality of Life.
|
12-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ho Cheung William Li, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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 19-053
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
product manufactured in and exported from the U.S.
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