A Resilience Promotion Program for Parents of Children With Cancer

October 13, 2020 updated by: The University of Hong Kong

Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.

Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having a child (0-19 years old) with cancer diagnosis.
  • Chinese resident and able to read Chinese and speak Mandarin.

Exclusion Criteria:

  • having physical impairment or cognitive and learning problems identified from family history of medical records.
  • attending other researches.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience promotion program
Subjects in the intervention group will participate in an eight-session resilience promotion program.
Other: Resilience promotion program
Resilience Promotion Program consists of eight sessions. Except the first orientation session and the last review session, other six sessions focus on cultivating the five internal resiliency factors (physical, behavioral, cognitive, emotional and spiritual). There are two sessions for behavioral factor, including one special to deal with the relationships between parents and children.
No Intervention: Treatment as usual
Treatment as usual for subjects in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of resilience from baseline to 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
The primary outcome measure is the resilience of subjects at 6-month follow-up when compare to baseline. The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of resilience at baseline
Time Frame: baseline
The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
baseline
Change in levels of resilience from baseline to 2-month follow-up between intervention and control group
Time Frame: 2-month follow-up
The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
2-month follow-up
Levels of quality of life at baseline
Time Frame: baseline
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
baseline
Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group
Time Frame: 2-month follow-up
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
2-month follow-up
Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
6-month follow-up
Levels of depression at baseline
Time Frame: baseline
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
baseline
Change in levels of depression from baseline to 2-month follow-up between intervention and control group
Time Frame: 2-month follow-up
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
2-month follow-up
Change in levels of depression from baseline to 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
6-month follow-up
Levels of anxiety at baseline
Time Frame: baseline
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
baseline
Change in levels of anxiety from baseline to 2-month follow-up between intervention and control group
Time Frame: 2-month follow-up
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
2-month follow-up
Change in levels of anxiety from baseline to 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
6-month follow-up
Levels of stress at baseline
Time Frame: baseline
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
baseline
Change in levels of stress from baseline to 2-month follow-up between intervention and control group
Time Frame: 2-month follow-up
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
2-month follow-up
Change in levels of stress from baseline to 6-month follow-up between intervention and control group
Time Frame: 6-month follow-up
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Yuan Hui Luo, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2019

Primary Completion (Actual)

July 21, 2020

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UW 19-436

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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