Enhancing Coping and Communication in Children With Cancer and Their Parents

Study Overview
=================
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.

Official Title
-----------------
Enhancing Coping and Communication in Children With Cancer and Their Parents: A Novel Internet Intervention

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Behavioral: Online Program to Support Coping and Communication in Families


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>Families will receive the online program to support coping and communication near the time of a child's cancer diagnosis | Behavioral: Online Program to Support Coping and Communication in Families<br>* Parents and children will access online materials designed to support the use of effective ways to cope with the diagnosis and treatment of cancer and to support open and communication.<br>|
| Active Comparator: Delayed Intervention<br>Families will receive the online program to support coping and communication approximately 6 months after a child's cancer diagnosis | Behavioral: Online Program to Support Coping and Communication in Families<br>* Parents and children will access online materials designed to support the use of effective ways to cope with the diagnosis and treatment of cancer and to support open and communication.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Behavior Problems on the Child Behavior Checklist from baseline to 6 months | Change in parents' report on the Child Behavior Checklist (a measure of their children's total emotional and behavioral problems). | The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups | 
| Change in Total Behavior Problems on the Youth Self Report from baseline to 6 months | Change in children's report on the Youth Self Report (a measure of their children's total emotional and behavioral problems). | This measure will be completed near the time of entry into the study and repeated at 6 month follow ups | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric cancer, Coping