NCT03983148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

June 10, 2019

Last Update Submit

November 3, 2020

Conditions

Keywords

Motivational InterviewingParentChildrenCancerPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in levels of physical activity from baseline to 12-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

    12-month follow-up

Secondary Outcomes (14)

  • Parents' self-efficacy at baseline

    baseline

  • Change of parents' self-efficacy from baseline at 6-month follow-up between intervention and control group

    6-month follow up

  • Change of parents' self-efficacy from baseline at 12-month follow-up between intervention and control group

    12-month follow up

  • Children's stages of change at baseline

    baseline

  • Change in children's stages of change from baseline at 6-month follow-up between intervention and control group

    6-month follow up

  • +9 more secondary outcomes

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

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

Placebo control

PLACEBO COMPARATOR

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

Interventions

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.

Motivational interviewing
Placebo controlBEHAVIORAL

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.

Placebo control

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ho Cheung William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Cheung Li, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 12, 2019

Study Start

June 1, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations