A Brief Parental Intervention on Learning and Education in Childhood Cancer

Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer

The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Brief Psychoeducational Intervention

Detailed Description

After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• parent(s) or legal guardian(s) of children with cancer
• preferred language for oral and written communication is English
• 18 years of age or older
• 1 or 2 parents or legal guardians can participate for each child

The child must also meet the following for the parent(s)/legal guardian(s) to participate:

• diagnosis of cancer
• child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
• child is between the age of 3 and 14
• child resides in New Mexico

Exclusion Criteria: Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth & Families Department).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Psychoeducational Intervention; Parents of children with cancer who complete the study participate in a brief, 1-session psychoeducational intervention.	Behavioral: Brief Psychoeducational Intervention; The 1-session psychoeducational intervention is divided into three brief modules. Topics that are covered include thinking, learning, emotional, and behavioral functioning as they relate to childhood cancer, educational and school supports, and the role of neuropsychological and school-based assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study recruitment and enrollment	Among qualifying families, the number receiving recruitment information about the study, identifying interest, scheduling, and completing procedures. Note, for each qualifying family, one or two parents or legal guardians are able to enroll in the study. This is a parental intervention and the child with cancer does not participate in the study.	Through study completion, up to 2 years
Fidelity to the intervention protocol	Interventions are audio-recorded. Percent adherence to the intervention protocol per a fidelity form, developed for this study, is assessed by an independent rater of fidelity.	at time of intervention (day 1)
Acceptability of the intervention	Ratings are provided on intervention acceptability as part of the Program Evaluation Form, a questionnaire developed for this study.	immediately post-intervention (day 1)

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Hyundai Hope On Wheels
• Investigators: Principal Investigator: Eric Zimak, PhD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No