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

Illness Management and Parental Adjustment to Cancer Treatment

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: University of Oklahoma
Oklahoma State University
Dayton Children's Hospital

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Unknown status
Start Date November 2015
Completion Date March 2020
Primary Completion Date March 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. Change in GSI score from baseline to 1-week post-intervention
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. 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. 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. Change in GSI score from baseline to 12-month post-intervention
Secondary Outcome
Measure Time Frame
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
Enrollment 296
Condition
Intervention

Intervention type: Behavioral

Intervention name: IMPACT

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.

Arm group label: Parent Uncertainty Intervention

Other name: Parent Uncertainty Management Intervention

Intervention type: Other

Intervention name: ESO

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.

Arm group label: Education/Support Only

Other name: Education/Support Only

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

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ahna LH Pai, PhD Principal Investigator Children's Hospital Medical Center, Cincinnati
Overall Contact

Last name: Ahna LH Pai, PhD

Phone: 513-803-0406

Email: [email protected]

Location
facility status contact contact_backup investigator
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Ahna LH Pai, PhD 513-803-0406 [email protected] Ahna LH Pai, PhD Principal Investigator
Dayton Children's Hospital | Dayton, Ohio, United States Recruiting Ayman El-Sheikh, MD
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting Larry Mullins, PhD 405-744-5663 [email protected]
Location Countries

United States

Verification Date

December 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Parent Uncertainty Intervention

Arm group type: Experimental

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.

Arm group label: Education/Support Only

Arm group type: Other

Description: 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.

Acronym IMPACT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov