Illness Management and Parental Adjustment to Cancer Treatment

Lymphoma Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505165
• Other study ID #: NR014248
• Status: Completed
• Phase: N/A
• Start date: November 19, 2015
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: February 1, 2022
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Leukemia
• Lymphoma
• Neoplasms
• Solid Tumor

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Dayton Children's Hospital	Dayton	Ohio
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Dayton Children's Hospital, Oklahoma State University, University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 Psyc — View 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( — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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