Clinical trial NCT04038242: A Resilience Promotion Program for Parents of Children With Cancer
Official title: A Resilience Promotion Program for Parents of Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parents of Children With Cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Change in levels of resilience from baseline to 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Levels of resilience at baseline
timeFrame: baseline
measure: Change in levels of resilience from baseline to 2-month follow-up between intervention and control group
timeFrame: 2-month follow-up
measure: Levels of quality of life at baseline
timeFrame: baseline
measure: Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group
timeFrame: 2-month follow-up
measure: Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Levels of depression at baseline
timeFrame: baseline
measure: Change in levels of depression from baseline to 2-month follow-up between intervention and control group
timeFrame: 2-month follow-up
measure: Change in levels of depression from baseline to 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Levels of anxiety at baseline
timeFrame: baseline
measure: Change in levels of anxiety from baseline to 2-month follow-up between intervention and control group
timeFrame: 2-month follow-up
measure: Change in levels of anxiety from baseline to 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Levels of stress at baseline
timeFrame: baseline
measure: Change in levels of stress from baseline to 2-month follow-up between intervention and control group
timeFrame: 2-month follow-up
measure: Change in levels of stress from baseline to 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Yuan Hui Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.