Illness Management and Parental Adjustment to Cancer Treatment

NCT02505165 | Completed DMC

• 1 other identifier: NR014248
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

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

  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)

  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)

  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)

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

Study Arms (2)

Parent Uncertainty Intervention

EXPERIMENTAL

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

Education/Support Only

OTHER

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

Interventions

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.

Also known as: Parent Uncertainty Management Intervention

Parent Uncertainty 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.

Also known as: Education/Support Only

Education/Support Only

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Oklahoma: collaborator
• Oklahoma State University: collaborator
• Dayton Children's Hospital: collaborator

Study Sites (3)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (6)

• 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.

  PMID: 28177514 BACKGROUND

• 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.

  PMID: 32196095 BACKGROUND

• 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.

  PMID: 26836990 RESULT

• 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.

  PMID: 28652227 RESULT

• 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.

  PMID: 34350968 RESULT

• 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.

  PMID: 28659258 DERIVED

MeSH Terms

Conditions

Leukemia; Lymphoma; Brain Neoplasms; Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ahna LH Pai, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 22, 2015
• Study Start: November 19, 2015
• Primary Completion: April 22, 2021
• Study Completion: February 1, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (3)