A Resilience Promotion Program for Parents of Children With Cancer

NCT04038242 | Completed

• 1 other identifier: UW 19-436
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Parents of Children With Cancer

Outcome Measures

Primary Outcomes (1)

• Change in levels of resilience from baseline to 6-month follow-up between intervention and control group

  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 Outcomes (14)

• Levels of resilience at baseline

  baseline

• Change in levels of resilience from baseline to 2-month follow-up between intervention and control group

  2-month follow-up

• Levels of quality of life at baseline

  baseline

• Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group

  2-month follow-up

• Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group

  6-month follow-up

Study Arms (2)

Resilience promotion program

EXPERIMENTAL

Subjects in the intervention group will participate in an eight-session resilience promotion program.

Other: Resilience promotion program

Treatment as usual

NO INTERVENTION

Treatment as usual for subjects in the control group.

Interventions

Resilience promotion program OTHER

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.

Resilience promotion program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

• Luo Y, Li HCW, Cheung AT, Ho LLK, Xia W, Zhang J. Evaluating the experiences of parents of children with cancer engaging in a mobile device-based resilience training programme: a qualitative study. Support Care Cancer. 2022 Jul;30(7):6205-6214. doi: 10.1007/s00520-022-07066-7. Epub 2022 Apr 20.

  PMID: 35441899 DERIVED

• Luo Y, Xia W, Cheung AT, Ho LLK, Zhang J, Xie J, Xiao P, Li HCW. Effectiveness of a Mobile Device-Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial. J Med Internet Res. 2021 Nov 29;23(11):e27639. doi: 10.2196/27639.

  PMID: 34847060 DERIVED

Study Officials

• Yuan Hui Luo, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 30, 2019
• Study Start: August 13, 2019
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

HK (1)