Illness Management and Parental Adjustment to Cancer Treatment (IMPACT)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Solid Tumor; Brain Tumor; Lymphoma; Leukemia

Treatments: Other: ESO; Behavioral: IMPACT

Study type: Interventional

Funder types: Other

Identifiers

NCT02505165

NR014248

Details and patient eligibility

About

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.

Full 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.

Enrollment: 279 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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279 participants in 2 patient groups

Parent Uncertainty Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: IMPACT

Education/Support Only

Other group

Description:

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.

Treatment:

Other: ESO