A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Tumor
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 279
- Locations
- 3
- Primary Endpoint
- Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
Time Frame: 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.
Time Frame: Change in GSI score from baseline to 12-month post-intervention
indicator of global psychological symptoms
Secondary Outcomes
- 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)