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TerminatedNCT05051800ALSFUpdated Sep 21, 2021

Enhancing Coping and Communication in Children With Cancer and Their Parents

An interventional study of Online Program to Support Coping and Communication in Families in Pediatric Cancer, sponsored by Vanderbilt University. Terminated at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Supportive care

Why this study was terminated
Recruitment of participants was interrupted by the COVID-19 pandemic and the funding for the study ended before the targeted enrollment could be completed.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2019, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric Cancer

Keywords

  • Pediatric cancer
  • Coping
03

In context

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Significant intellectual disability that would interfere with completing the online program
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Early Intervention

    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

  • Active comparator
    Delayed Intervention

    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

  • BehavioralOnline 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups

  2. 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).

    Time frame: This measure will be completed near the time of entry into the study and repeated at 6 month follow ups

07

Study locations

1 site
  • Vanderbilt University
    Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05051800
Lead sponsor
Vanderbilt University
Collaborators
Nationwide Children's Hospital
Responsible party
Bruce Compas (Patricia and Rodes Hart Professor, Vanderbilt University) — Principal investigator
First posted
Sep 21, 2021
Start date
Feb 1, 2019
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Sep 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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