Clinical trial NCT05051800: Enhancing Coping and Communication in Children With Cancer and Their Parents
Official title: Enhancing Coping and Communication in Children With Cancer and Their Parents: A Novel Internet Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Cancer
Keywords: Pediatric cancer
Coping
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2021-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Recruitment and randomization of participants into an online support program vs. usual care. Participants in the usual care condition offered the program after 6 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.

Detailed description: Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. This online program includes modules to teach parenting, communication and coping skills to parents of children with cancer, and coping skills to their children who have been recently diagnosed with cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.

Eligibility criteria: Inclusion Criteria:

* Child from ages 10 to 17 years old who has been diagnosed with cancer

Exclusion Criteria:

* Significant intellectual disability that would interfere with completing the online program

Primary outcomes:
measure: Change in Total Behavior Problems on the Child Behavior Checklist from baseline to 6 months
timeFrame: The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups
measure: Change in Total Behavior Problems on the Youth Self Report from baseline to 6 months
timeFrame: This measure will be completed near the time of entry into the study and repeated at 6 month follow ups
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References: