Illness Management and Parental Adjustment to Cancer Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Solid Tumor, Leukemia, Lymphoma, Brain Tumor

Intervention / Treatment
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* Behavioral: IMPACT
* Other: ESO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Uncertainty Intervention<br>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<br>* • 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.<br>* Other names: Parent Uncertainty Management Intervention;|
| Other: Education/Support Only<br>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<br>* 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.<br>* Other names: Education/Support Only;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumor, Intervention, Illness Uncertainty, Childhood Cancer, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial, Parental uncertainty management intervention, Parent, Oncology, Pediatric