Illness Management and Parental Adjustment to Cancer Treatment (IMPACT)

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: Completed
• Conditions: Lymphoma; Leukemia; Solid Tumor; Brain Tumor
• Intervention / Treatment: Behavioral: IMPACT; Other: ESO

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: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.	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.	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.	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.	indicator of global psychological symptoms	Change in GSI score from baseline to 12-month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)	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)	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)	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)	Measure of caregiver post-traumatic stress symptoms	Change in IES-R total score score from baseline to 12-month post-intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Oklahoma; Oklahoma State University; Dayton Children's Hospital
• Investigators: Principal Investigator: Ahna LH Pai, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2015
• Primary Completion (Actual): April 22, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Pediatric; Brain Tumor; Lymphoma; Leukemia; Oncology; Intervention; Childhood Cancer; Solid Tumor; Parent; Illness Uncertainty; Parental uncertainty management intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Brain Neoplasms
• Other Study ID 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