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Motivational Interviewing With Parents to Adopt and Maintain Physical Activity

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ClinicalTrials.gov Identifier: NCT03983148
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:

Cancer-related fatigue is the most commonly reported symptom among children with cancer and its effect is long-lasting, remaining for years after treatment.Childhood cancer patients undergo chemotherapy and/or radiotherapy that impairs their normal body tissue and fitness. Consequently, cardiorespiratory function and muscle strength decrease, and fatigue is inevitable. More importantly, these complications do not disappear, but continue for months or even years after completion of therapy.

Increasing concern has been placed on the benefits of regular physical activity (PA) among young cancer patients to improve cardiovascular fitness, ameliorate fatigue, and reduce some of the adverse effects of cancer and its treatment. Various studies have shown improvements in quality of life among young patients undergoing cancer treatment by performing regular physical activity. However, the literature review found that most young cancer patients maintain a lower level of PA than before their diagnosis.

A recent study revealed that the current PA levels of Hong Kong young cancer patients were markedly reduced when compared with their pre-morbid situation. Moreover, they were significantly less active in performing physical exercise, and reported lower levels of quality of life than their healthy counterparts. These findings reveal a crucial obligation of health care professionals to advocate the significance of regular PA among young cancer patients.

It is crucial for healthcare to correct misconceptions about PA among parents of children with cancer and advocate the principle of regular PA for their children, with the aim of enhancing their physical and psychological wellbeing and promoting their quality of life. Nevertheless, a large body of evidence has shown that education alone is insufficient or unlikely to change behavior, and healthcare professionals must therefore explore strategies that can actually be effective in helping parents realize the importance of regular physical activities for their children with cancer. Most importantly, healthcare professionals should motivate parents, as the primary caregivers, especially during children's cancer treatment, to take an important role in encouraging their children with cancer to adopt regular PA.

This study aims at testing the effectiveness of using motivational interviewing with parents in encouraging their children with cancer to adopt and maintain regular physical activity.


Condition or disease Intervention/treatment Phase
Pediatric Cancer Behavioral: Motivational interviewing Behavioral: Placebo control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Motivational Interviewing With Parents in Encouraging Their Children With Cancer to Adopt and Maintain Regular Physical Activity
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motivational interviewing
Other than usual medical care received by children, their parents in this group will receive three individual, face-to-face interventions on motivational interviewing by a trained registered nurse at baseline, 3-month and 6-month, with each session is about 60 minutes. All sessions of motivational interviewing will be scheduled based on the treatment schedule of the children and conducted in an interview room inside the pediatric oncology unit. A 25-30 minutes semi -structured interview will be conducted for process evaluation at 6-month.
Behavioral: Motivational interviewing
There are 3 sessions. Each session is an about 60-minute individual motivational interviewing held by a trained registered nurse. The first session aims to develop an action plan that enables the parents to promote physical activity (PA) for their children. The second session targets to review the adherence to the action plan. The nurse will discuss the progress. In the last session, the aim is to motivate the parents promoting PA for their children in the long run. As such, the benefits of PA throughout the survivorship will be emphasized. And the nurse will work with the parents to identify the resources that can help maintain the designed action plan.

Placebo Comparator: Placebo control

Other than usual medical care received by children, parents in this group will receive an individual, face-to-face intervention which mimics the time and attention received by those in the experimental group. The intervention includes three sessions of educational talk to parents of children with cancer on healthy diet for cancer patients, adverse effects of cancer treatment, methods to minimize adverse effects.

Subjects in both groups will receive a booklet developed by the advisory committee, which contains a various kind of physical activities specially designed for children with cancer.

Behavioral: Placebo control

Other than usual medical care received by children, parents in this group will receive an individual, face-to-face intervention which mimics the time and attention received by those in the experimental group. The intervention includes three sessions of educational talk to parents of children with cancer on healthy diet for cancer patients, adverse effects of cancer treatment, methods to minimize adverse effects.

Subjects in both groups will receive a booklet developed by the advisory committee, which contains a various kind of physical activities specially designed for children with cancer.





Primary Outcome Measures :
  1. 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 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


Secondary Outcome Measures :
  1. Parents' self-efficacy at baseline [ Time Frame: baseline ]
    Self-efficacy of parents will be assessed by asking parents to rate their confidence in engaging their children physically active by using 5-point Likert-type scales ranging from "not confident" to "extremely confident."

  2. Change of parents' self-efficacy from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ]
    Self-efficacy of parents will be assessed by asking parents to rate their confidence in engaging their children physically active by using 5-point Likert-type scales ranging from "not confident" to "extremely confident."

  3. Change of parents' self-efficacy from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ]
    Self-efficacy of parents will be assessed by asking parents to rate their confidence in engaging their children physically active by using 5-point Likert-type scales ranging from "not confident" to "extremely confident."

  4. Children's stages of change at baseline [ Time Frame: baseline ]
    The PASCQ (Appendix 5)will be used to assess the stages of change about physical activity. This scale contains 4 items and the participants have to answer "yes" or "no" for each of them. With reference to their responses, they are then classified into one of the five stages, including pre-contemplation, contemplation, preparation, action and maintenance.

  5. Change in children's stages of change from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ]
    The PASCQ (Appendix 5)will be used to assess the stages of change about physical activity. This scale contains 4 items and the participants have to answer "yes" or "no" for each of them. With reference to their responses, they are then classified into one of the five stages, including pre-contemplation, contemplation, preparation, action and maintenance.

  6. Change in children's stages of change from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ]
    The PASCQ (Appendix 5)will be used to assess the stages of change about physical activity. This scale contains 4 items and the participants have to answer "yes" or "no" for each of them. With reference to their responses, they are then classified into one of the five stages, including pre-contemplation, contemplation, preparation, action and maintenance.

  7. Levels of cancer-related fatigue at baseline [ Time Frame: baseline ]
    The FS-C is designed to assess the severity of fatigue for cancer children aged 9 to 16. This scale contains 14 items which are evaluated on a five-point Likert scale (1= "Not at all"; 2= "A little"; 3= "Some"; 4= "Quite a bit" and 5= "A lot"). The children are asked to indicate their fatigue level over the past 7 days. The possible range of scores is from 14 to 70, with higher scores indicating higher levels of fatigue.

  8. 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 ]
    The FS-C is designed to assess the severity of fatigue for cancer children aged 9 to 16. This scale contains 14 items which are evaluated on a five-point Likert scale (1= "Not at all"; 2= "A little"; 3= "Some"; 4= "Quite a bit" and 5= "A lot"). The children are asked to indicate their fatigue level over the past 7 days. The possible range of scores is from 14 to 70, with higher scores indicating higher levels of fatigue.

  9. 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 ]
    The FS-C is designed to assess the severity of fatigue for cancer children aged 9 to 16. This scale contains 14 items which are evaluated on a five-point Likert scale (1= "Not at all"; 2= "A little"; 3= "Some"; 4= "Quite a bit" and 5= "A lot"). The children are asked to indicate their fatigue level over the past 7 days. The possible range of scores is from 14 to 70, with higher scores indicating higher levels of fatigue.

  10. Quality of life at baseline [ Time Frame: baseline ]
    The Quality of life of the participants will be measured by the Chinese version of the PedsQL (Appendix 7) cancer module v. 3.0. All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month.

  11. Change in quality of life from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ]
    The Quality of life of the participants will be measured by the Chinese version of the PedsQL (Appendix 7) cancer module v. 3.0. All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month.

  12. Change in quality of life from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ]
    The Quality of life of the participants will be measured by the Chinese version of the PedsQL (Appendix 7) cancer module v. 3.0. All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month.

  13. 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

  14. 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 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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (Children)

  • aged between 9 to 16
  • diagnosed with cancer at some time in previous six months and currently admit for cancer treatments
  • do not participate in physical exercise and do not intend to start exercising in the next 6 months (pre-contemplation)
  • who are able to speak Cantonese and read Chinese.

Exclusion Criteria:(Children)

  • children with evidence of recurrence or second malignancies
  • those with physical impairment or cognitive and learning problems identified from their medical records

Inclusion Criteria: (Parents)

  • must be able to speak Cantonese and read Chinese
  • one parent (either father or mother) who should be the main carer for the child with cancer will be selected

Exclusion Criteria: (Parents)

  • Parents with emotional or psychiatric disorders, and cognitive and learning problems identified from their medical records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983148


Contacts
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Contact: Ho Cheung Li, PhD 39176634 william3@hku.hk

Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ho Cheung William Li, PhD The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03983148     History of Changes
Other Study ID Numbers: HKCH-REC-2019-018
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:
Motivational Interviewing
Parent
Children
Cancer
Physical activity

Additional relevant MeSH terms:
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Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents