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Childhood CancerNCT03859271

Using Information Communication Technology to Deliver Brief Motivational Interviewing

A study testing Brief motivational interviewing in people with Childhood Cancer, run by The University of Hong Kong at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 9 to 16 years
Conditions the study is for
Childhood Cancer
What is being tested?
Brief motivational interviewing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
2 sitesin 2 countries
Study dates
11 Mar 2019to 29 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site
  • The University of Hong Kong

    Hong Kong

Other trials in China

Hong Kong1 site
  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Brief motivational interviewing, Placebo control
Keywords
Physical activity
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief motivational interviewingBehavioural

    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 controlBehavioural

    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.

Study groups in NCT03859271
Study groupRoleWhat they receive
brief motivational interviewingExperimentalParticipants 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.
Receives: Behavioral: Brief motivational interviewing
Placebo ControlPlacebo comparatorChildren 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.
Receives: Behavioral: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12-month follow-up

Secondary outcomes (24)
  1. 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.

    Measured: baseline

  2. 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.

    Measured: 1-month follow-up

  3. 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.

    Measured: 3-month follow-up

  4. 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.

    Measured: 6-month follow-up

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: 1-month follow-up

  7. 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.

    Measured: 3-month follow-up

  8. 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.

    Measured: 6-month follow-up

  9. 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.

    Measured: 12-month follow-up

  10. Muscle strength at baseline

    Hand-held dynamometer (HHD) will be used to assess the children's right- and left-hand grip strengths.

    Measured: Baseline

  11. 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.

    Measured: 1-month follow-up

  12. 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.

    Measured: 3-month follow-up

  13. 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.

    Measured: 6-month follow-up

  14. 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.

    Measured: 12-month follow-up

  15. Lung functionality at baseline

    A mini-Wright Standard Handheld peak flow meter will be used to determine subjects' peak expiratory flow.

    Measured: Baseline

  16. 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.

    Measured: 1-month follow-up

  17. 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.

    Measured: 3-month follow-up

  18. 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.

    Measured: 6-month follow-up

  19. 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.

    Measured: 12-month follow-up

  20. 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.

    Measured: Baseline

  21. 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.

    Measured: 1-month follow-up

  22. 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.

    Measured: 3-month follow-up

  23. 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.

    Measured: 6-month follow-up

  24. 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.

    Measured: 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start11 Mar 2019
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859271
Sponsor's protocol ID
UW 19-053
Status last verified
Nov 2020
First submitted
27 Feb 2019
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35699959

Questions about this trial

What is this clinical trial studying?

A study testing Brief motivational interviewing in people with Childhood Cancer, run by The University of Hong Kong at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in levels of physical activity from baseline to 12-month follow-up between intervention and control group (time frame: 12-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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