Clinical trial NCT03859271: Using Information Communication Technology to Deliver Brief Motivational Interviewing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: Physical activity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 161
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in levels of physical activity from baseline to 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Levels of physical activity at baseline
timeFrame: baseline
measure: Change in levels of physical activity from baseline at 1-month follow-up between intervention and control group
timeFrame: 1-month follow-up
measure: Change in levels of physical activity from baseline at 3-month follow-up between intervention and control group
timeFrame: 3-month follow-up
measure: Change in levels of physical activity from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Levels of cancer-related fatigue at baseline
timeFrame: Baseline
measure: Change in levels of cancer-related fatigue from baseline at 1-month follow-up between intervention and control group
timeFrame: 1-month follow-up
measure: Change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group
timeFrame: 3-month follow-up
measure: Change in levels of cancer-related fatigue from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
measure: Muscle strength at baseline
timeFrame: Baseline
measure: Change in muscular strength from baseline at 1-month follow-up between intervention and control group
timeFrame: 1-month follow-up
measure: Change in muscular strength from baseline at 3-month follow-up between intervention and control group
timeFrame: 3-month follow-up
measure: Change in muscular strength from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Change in muscular strength from baseline at 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
measure: Lung functionality at baseline
timeFrame: Baseline
measure: Change in lung functionality from baseline at 1-month follow-up between intervention and control group
timeFrame: 1-month follow-up
measure: Change in lung functionality from baseline at 3-month follow-up between intervention and control group
timeFrame: 3-month follow-up
measure: Change in lung functionality from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Change in lung functionality from baseline at 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
measure: Quality of life at baseline
timeFrame: Baseline
measure: Change in quality of life from baseline at 1-month follow-up between intervention and control group
timeFrame: 1-month follow-up
measure: Change in quality of life from baseline at 3-month follow-up between intervention and control group
timeFrame: 3-month follow-up
measure: Change in quality of life from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Change in quality of life from baseline at 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.