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Completed

NCT Number: NCT02505165

Illness Management and Parental Adjustment to Cancer Treatment

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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Key information

Conditions

Solid Tumor Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMPaCT

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.

Other names: Parent Uncertainty Management Intervention

ESO

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.

Other names: Education/Support Only

Primary outcomes

  1. 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

  2. Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.

    Time frame: Change in GSI score from baseline to 3-month post-intervention

    indicator of global psychological symptoms

  3. Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.

    Time frame: Change in GSI score from baseline to 6-month post-intervention

    indicator of global psychological symptoms

  4. 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

  1. Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)

    Time frame: Change in IES-R total score score from baseline to 1-week post-intervention

    Measure of caregiver post-traumatic stress symptoms

  2. Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)

    Time frame: Change in IES-R total score score from baseline to 3-month post-intervention

    Measure of caregiver post-traumatic stress symptoms

  3. Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)

    Time frame: Change in IES-R total score score from baseline to 6-month post-intervention

    Measure of caregiver post-traumatic stress symptoms

  4. Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)

    Time frame: Change in IES-R total score score from baseline to 12-month post-intervention

    Measure of caregiver post-traumatic stress symptoms

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Dayton Children's Hospital
  • Oklahoma State University
  • University of Oklahoma

Registry information

Official study title

A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer

Acronym: IMPACT

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jul 22, 2015
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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