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A Resilience Promotion Program for Parents of Children With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038242
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Parents of Children With Cancer Other: Resilience promotion program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Resilience Promotion Program for Parents of Children With Cancer
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in levels of resilience from baseline to 1-month follow-up between intervention and control group [ Time Frame: 1-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.

  3. 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.

  4. Change in levels of quality of life from baseline to 1-month follow-up between intervention and control group [ Time Frame: 1-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.

  5. 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. 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.

  7. Change in levels of depression from baseline to 1-month follow-up between intervention and control group [ Time Frame: 1-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.

  8. 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.

  9. 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.

  10. Change in levels of anxiety from baseline to 1-month follow-up between intervention and control group [ Time Frame: 1-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.

  11. 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.

  12. 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.

  13. Change in levels of stress from baseline to 1-month follow-up between intervention and control group [ Time Frame: 1-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.

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04038242


Locations
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Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yuan Hui Luo, PhD The University of Hong Kong
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04038242    
Other Study ID Numbers: UW 19-436
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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