Clinical trial NCT02505165: Illness Management and Parental Adjustment to Cancer Treatment
Official title: A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
name: Oklahoma State University
name: Dayton Children's Hospital
First posted: 2015-07-22
Enrollment: 279
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
timeFrame: Change in (global severity index) GSI score from baseline to 1-week post-intervention
measure: Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
timeFrame: Change in GSI score from baseline to 3-month post-intervention
measure: Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
timeFrame: Change in GSI score from baseline to 6-month post-intervention
measure: Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
timeFrame: Change in GSI score from baseline to 12-month post-intervention
Secondary outcomes:
measure: Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
timeFrame: Change in IES-R total score score from baseline to 1-week post-intervention
measure: Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
timeFrame: Change in IES-R total score score from baseline to 3-month post-intervention
measure: Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
timeFrame: Change in IES-R total score score from baseline to 6-month post-intervention
measure: Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
timeFrame: Change in IES-R total score score from baseline to 12-month post-intervention
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ahna LH Pai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.