Enhancing Coping and Communication in Children With Cancer and Their Parents

Pediatric Cancer Clinical Trial

— ALSF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05051800
• Other study ID #: IRB 170111
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Online Program to Support Coping and Communication in Families
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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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