Enhancing Coping and Communication in Children With Cancer and Their Parents

NCT ID: NCT05051800

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early Intervention

Families will receive the online program to support coping and communication near the time of a child's cancer diagnosis

Group Type EXPERIMENTAL

Online Program to Support Coping and Communication in Families

Intervention Type 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

Families will receive the online program to support coping and communication approximately 6 months after a child's cancer diagnosis

Group Type ACTIVE_COMPARATOR

Online Program to Support Coping and Communication in Families

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Bruce Compas

Patricia and Rodes Hart Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 170111

Identifier Type: -

Identifier Source: org_study_id

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