Solid Tumor, Leukemia, Lymphoma, Brain Tumor
Conditions
Keywords
Intervention, Illness Uncertainty, Childhood Cancer, Solid Tumor, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial, Parental uncertainty management intervention, Parent, Oncology, Pediatric
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.
Interventions
BEHAVIORALIMPACT
• 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.
OTHERESO
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.
Sponsors
University of Oklahoma
Oklahoma State University
Dayton Children's Hospital
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed