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Illness Management and Parental Adjustment to Cancer Treatment (IMPACT)

Primary Purpose

Solid Tumor, Leukemia, Lymphoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IMPACT

ESO

About this trial

This is an interventional supportive care trial for Solid Tumor focused on measuring Intervention, Illness Uncertainty, Childhood Cancer, Solid Tumor, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial, Parental uncertainty management intervention, Parent, Oncology, Pediatric

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Cincinnati Children's Hospital Medical Center
Dayton Children's Hospital
University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Parent Uncertainty Intervention

Education/Support Only

Arm 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.

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.

Outcomes

Primary Outcome Measures

Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.

indicator of global psychological symptoms

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

indicator of global psychological symptoms

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

indicator of global psychological symptoms

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

indicator of global psychological symptoms

Secondary Outcome Measures

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

Measure of caregiver post-traumatic stress symptoms

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

Measure of caregiver post-traumatic stress symptoms

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

Measure of caregiver post-traumatic stress symptoms

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

Measure of caregiver post-traumatic stress symptoms

Full Information

NCT ID

NCT02505165

First Posted

June 17, 2015

Last Updated

April 5, 2022

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02505165

Brief Title

Illness Management and Parental Adjustment to Cancer Treatment

Acronym

IMPACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

November 19, 2015 (Actual)

Primary Completion Date

April 22, 2021 (Actual)

Study Completion Date

February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumor, Leukemia, Lymphoma, Brain Tumor

Keywords

Intervention, Illness Uncertainty, Childhood Cancer, Solid Tumor, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial, Parental uncertainty management intervention, Parent, Oncology, Pediatric

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parent Uncertainty Intervention

Arm Type

Experimental

Arm Description

Arm Title

Education/Support Only

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

IMPACT

Other Intervention Name(s)

Parent Uncertainty Management Intervention

Intervention Description

• 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

Other

Intervention Name(s)

ESO

Other Intervention Name(s)

Education/Support Only

Intervention Description

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.

Primary Outcome Measure Information:

Title

Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.

Description

indicator of global psychological symptoms

Time Frame

Change in (global severity index) GSI score from baseline to 1-week post-intervention

Title

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

Description

indicator of global psychological symptoms

Time Frame

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

Title

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

Description

indicator of global psychological symptoms

Time Frame

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

Title

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

Description

indicator of global psychological symptoms

Time Frame

Change in GSI score from baseline to 12-month post-intervention

Secondary Outcome Measure Information:

Title

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

Description

Measure of caregiver post-traumatic stress symptoms

Time Frame

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

Title

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

Description

Measure of caregiver post-traumatic stress symptoms

Time Frame

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

Title

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

Description

Measure of caregiver post-traumatic stress symptoms

Time Frame

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

Title

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

Description

Measure of caregiver post-traumatic stress symptoms

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahna LH Pai, PhD

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Dayton Children's Hospital

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Citations:

PubMed Identifier

28177514

Citation

Szulczewski L, Mullins LL, Bidwell SL, Eddington AR, Pai ALH. Meta-Analysis: Caregiver and Youth Uncertainty in Pediatric Chronic Illness. J Pediatr Psychol. 2017 May 1;42(4):395-421. doi: 10.1093/jpepsy/jsw097.

Results Reference

background

PubMed Identifier

32196095

Citation

Sharkey CM, Schepers SA, Drake S, Pai ALH, Mullins LL, Grootenhuis MA. Psychosocial Risk Profiles Among American and Dutch Families Affected by Pediatric Cancer. J Pediatr Psychol. 2020 May 1;45(4):463-473. doi: 10.1093/jpepsy/jsaa012.

Results Reference

background

PubMed Identifier

26836990

Citation

Morrison CF, Szulczewski L, Strahlendorf LF, Lane JB, Mullins LL, Pai AL. Designing Technology to Address Parent Uncertainty in Childhood Cancer. ANS Adv Nurs Sci. 2016 Jan-Mar;39(1):15-25. doi: 10.1097/ANS.0000000000000100.

Results Reference

result

PubMed Identifier

28652227

Citation

Marsolo K, Shuman W, Nix J, Morrison CF, Mullins LL, Pai AL. Reducing Parental Uncertainty Around Childhood Cancer: Implementation Decisions and Design Trade-Offs in Developing an Electronic Health Record-Linked Mobile App. JMIR Res Protoc. 2017 Jun 26;6(6):e122. doi: 10.2196/resprot.7523.

Results Reference

result

PubMed Identifier

34350968

Citation

Basile NL, Chardon ML, Peugh J, Edwards CS, Szulczewski L, Morrison CF, Nagarajan R, El-Sheikh A, Chaney JM, Pai ALH, Mullins LL. Relationship Between Caregiver Uncertainty, Problem-Solving, and Psychological Adjustment in Pediatric Cancer. J Pediatr Psychol. 2021 Oct 18;46(10):1258-1266. doi: 10.1093/jpepsy/jsab065.

Results Reference

result

PubMed Identifier

28659258

Citation

Nebeker C, Murray K, Holub C, Haughton J, Arredondo EM. Acceptance of Mobile Health in Communities Underrepresented in Biomedical Research: Barriers and Ethical Considerations for Scientists. JMIR Mhealth Uhealth. 2017 Jun 28;5(6):e87. doi: 10.2196/mhealth.6494.

Results Reference

derived

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Illness Management and Parental Adjustment to Cancer Treatment

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