Illness Management and Parental Adjustment to Cancer Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-19

Study Completion Date

2022-02-01

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.

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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.

Conditions

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Solid Tumor Leukemia Lymphoma Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Parent Uncertainty Intervention

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.

Group Type EXPERIMENTAL

IMPACT

Intervention Type BEHAVIORAL

• 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.

Education/Support Only

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.

Group Type OTHER

ESO

Intervention Type OTHER

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.

Interventions

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IMPACT

• 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.

Intervention Type BEHAVIORAL

ESO

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.

Intervention Type OTHER

Other Intervention Names

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Parent Uncertainty Management Intervention Education/Support Only

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

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No