IMPACT: Illness Management and Parental Adjustment to Cancer Treatment

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT02505165

Collaborator

University of Oklahoma (Other), Oklahoma State University (Other), Dayton Children's Hospital (Other)

279

Enrollment

Locations

Arms

74.4

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the efficacy of a clinic-based intervention designed to reduce illness uncertainty for parents of children who have been recently diagnosed with cancer.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Leukemia Lymphoma Brain Tumor	Behavioral: IMPACT Other: ESO	N/A

Detailed Description

The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Participants will be randomly assigned to receive equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.

Study Design

Study Type:

Interventional

Actual Enrollment :

279 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer

Actual Study Start Date :

Nov 19, 2015

Actual Primary Completion Date :

Apr 22, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parent Uncertainty Intervention A pediatric cancer-specific, clinic based, six-module interdisciplinary uncertainty intervention. Modules one through three target uncertainty prevention. Modules four through six target uncertainty responses for situations in which uncertainty cannot be prevented or avoided.	Behavioral: IMPACT • The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist. Other Names: Parent Uncertainty Management Intervention
Other: Education/Support Only Sessions in this condition aim to provide education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Information presented will be based upon, "Young People with Cancer: A Handbook for Parents", a parent resource developed by the National Cancer Institute. Parents will also be provided with relevant educational brochures from COG. Each session will also include a structured set of questions that will facilitate discussion. All ESO interventionists will be trained in non-directive approaches including reflective listening. Content provided in the ESO sessions will offer valuable information to parents without providing the specific skills of the IMPACT.	Other: ESO This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist. Other Names: Education/Support Only

Arm

Intervention/Treatment

Experimental: Parent Uncertainty Intervention

A pediatric cancer-specific, clinic based, six-module interdisciplinary uncertainty intervention. Modules one through three target uncertainty prevention. Modules four through six target uncertainty responses for situations in which uncertainty cannot be prevented or avoided.

Behavioral: IMPACT

• The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.

Other Names:

Parent Uncertainty Management Intervention

Other: Education/Support Only

Sessions in this condition aim to provide education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Information presented will be based upon, "Young People with Cancer: A Handbook for Parents", a parent resource developed by the National Cancer Institute. Parents will also be provided with relevant educational brochures from COG. Each session will also include a structured set of questions that will facilitate discussion. All ESO interventionists will be trained in non-directive approaches including reflective listening. Content provided in the ESO sessions will offer valuable information to parents without providing the specific skills of the IMPACT.

Other: ESO

This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.

Other Names:

Education/Support Only

Outcome Measures

Primary Outcome Measures

Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90. [Change in (global severity index) GSI score from baseline to 1-week post-intervention]
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. [Change in GSI score from baseline to 3-month post-intervention]
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. [Change in GSI score from baseline to 6-month post-intervention]
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. [Change in GSI score from baseline to 12-month post-intervention]
indicator of global psychological symptoms

Secondary Outcome Measures

Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) [Change in IES-R total score score from baseline to 1-week post-intervention]
Measure of caregiver post-traumatic stress symptoms
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) [Change in IES-R total score score from baseline to 3-month post-intervention]
Measure of caregiver post-traumatic stress symptoms
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) [Change in IES-R total score score from baseline to 6-month post-intervention]
Measure of caregiver post-traumatic stress symptoms
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) [Change in IES-R total score score from baseline to 12-month post-intervention]
Measure of caregiver post-traumatic stress symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The child has been diagnosed with leukemia or lymphoma, malignant solid tumor, or malignant brain tumor
The child is being treated for cancer and returning to the medical center (CCHMC or OUHSC).
The child is 18 years of age or younger
Recruitment occurs within 2-12 weeks post diagnosis
The parent is responsible for care and is willing to give consent and participate
The child is willing to give assent or consent and participate (only for children 8 years old and older)
The parent gives patient permission to participate.
Parent is fluent in English

Exclusion Criteria:

The child is experiencing an imminent medical crisis necessitating significant medical intervention
The child with cancer is determined to be in the terminal phase of illness and/or is receiving end of life care
The diagnosis is determined to be a relapse or a second malignancy
The parent is currently being treated for a serious psychiatric disorder, or, evidences mental retardation
The parent is younger than 18 years of age
The parent is not English speaking
The parent is unwilling to give written permission for child participation
If the patient's treatment visit schedule is too infrequent to meet the study visit timeline requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
2	Dayton Children's Hospital	Dayton	Ohio	United States	45404
3	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104