Illness Management and Parental Adjustment to Cancer Treatment

Not Applicable

Completed

• Conditions: Solid Tumor; Leukemia; Brain Tumor; Lymphoma
• Interventions: Other: ESO; Behavioral: IMPACT

• Registration Number: NCT02505165
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

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 Timeline

• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Study Start: 2015-11-19
• Primary Completion: 2021-04-22
• Study Completion: 2022-02-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education/Support Only	ESO	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.
Parent Uncertainty Intervention	IMPACT	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.

Primary Outcome Measures

Name	Time	Method
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 12-month post-intervention	indicator of global psychological symptoms

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Dayton Children's Hospital; 🇺🇸 Dayton, Ohio, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States