Enhancing Coping and Communication in Children With Cancer and Their Parents

NCT05051800 | Terminated

• 1 other identifier: IRB 170111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Pediatric cancer; Coping

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Early Intervention

EXPERIMENTAL

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

Delayed Intervention

ACTIVE COMPARATOR

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

Interventions

Online Program to Support Coping and Communication in Families BEHAVIORAL

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.

Delayed Intervention; Early Intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patricia and Rodes Hart Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: September 21, 2021
• Study Start: February 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)