Illness Management and Parental Adjustment to Cancer Treatment (IMPACT)

April 5, 2022 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Dayton, Ohio, United States, 45404
        • Dayton Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Other Names:
  • Parent Uncertainty Management Intervention
Other: 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.
Other: 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.
Other Names:
  • Education/Support Only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in (global severity index) GSI score from baseline to 1-week post-intervention
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
Change in GSI score from baseline to 3-month post-intervention
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
Change in GSI score from baseline to 6-month post-intervention
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
Change in GSI score from baseline to 12-month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change in IES-R total score score from baseline to 1-week post-intervention
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
Change in IES-R total score score from baseline to 3-month post-intervention
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
Change in IES-R total score score from baseline to 6-month post-intervention
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
Change in IES-R total score score from baseline to 12-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oklahoma
Oklahoma State University
Dayton Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahna LH Pai, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NR014248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to the sensitive nature of the measures that provided information on the participants psychologically symptoms the final dataset will be stripped of identifiers prior to any release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics due the relatively rare pediatric oncological diagnoses of the children in the study. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using the highest standards of practice; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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