Using Information Communication Technology to Deliver Brief Motivational Interviewing

Childhood Cancer Clinical Trial

Official title:

Using Information Communication Technology to Deliver Brief Motivational Interviewing to Promote Regular Physical Activity Among Chinese Childhood Cancer Survivors: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859271
• Other study ID #: UW 19-053
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: November 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Behavioral:
• Brief motivational interviewing
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 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.

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Levels of physical activity at 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
Secondary	Change in levels of physical activity from baseline at 1-month follow-up between intervention and control group	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
Secondary	Change in levels of physical activity from baseline at 3-month follow-up between intervention and control group	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
Secondary	Change in levels of physical activity from baseline at 6-month follow-up between intervention and control group	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
Secondary	Levels of cancer-related fatigue at 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
Secondary	Change in levels of cancer-related fatigue from baseline at 1-month follow-up between intervention and control group	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
Secondary	Change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group	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
Secondary	Change in levels of cancer-related fatigue from baseline at 6-month follow-up between intervention and control group	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
Secondary	Change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group	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
Secondary	Muscle strength at baseline	Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.	Baseline
Secondary	Change in muscular strength from baseline at 1-month follow-up between intervention and control group	Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.	1-month follow-up
Secondary	Change in muscular strength from baseline at 3-month follow-up between intervention and control group	Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.	3-month follow-up
Secondary	Change in muscular strength from baseline at 6-month follow-up between intervention and control group	Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.	6-month follow-up
Secondary	Change in muscular strength from baseline at 12-month follow-up between intervention and control group	Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.	12-month follow-up
Secondary	Lung functionality at baseline	A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.	Baseline
Secondary	Change in lung functionality from baseline at 1-month follow-up between intervention and control group	A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.	1-month follow-up
Secondary	Change in lung functionality from baseline at 3-month follow-up between intervention and control group	A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.	3-month follow-up
Secondary	Change in lung functionality from baseline at 6-month follow-up between intervention and control group	A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.	6-month follow-up
Secondary	Change in lung functionality from baseline at 12-month follow-up between intervention and control group	A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.	12-month follow-up
Secondary	Quality of life at 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
Secondary	Change in quality of life from baseline at 1-month follow-up between intervention and control group	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
Secondary	Change in quality of life from baseline at 3-month follow-up between intervention and control group	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
Secondary	Change in quality of life from baseline at 6-month follow-up between intervention and control group	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
Secondary	Change in quality of life from baseline at 12-month follow-up between intervention and control group	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