PLAY Program for Caregivers of Childhood Cancer Survivors

This study is testing an online program called the PLAY Program, designed for caregivers of young children who have survived cancer. The program has seven modules covering topics like self-care, relationships, and preparing children for school. Researchers want to see if the PLAY Program can help caregivers with positive parenting, reduce their stress, and get young children ready for school. To join, you must be the legal guardian of a childhood cancer survivor, live with the child over 50% of the time, speak English, and live within 150 miles of Nationwide Children's Hospital. The study aims to understand if caregivers are willing to use the program and complete assessments.

Study design
This study is an interventional study with a planned enrollment of 105 participants. It will occur in two phases: an initial rapid testing phase and then a single-arm trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Assessments will be measured at 3 months post-enrollment, with additional 6-month assessments in Phase II.

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NCT06769334

Preparing for Life and Academics for Young Childhood Cancer Survivors

Recruiting
NAAll AgesInterventionalSupportive care
Nationwide Children's Hospital
~105 participants
Updated 2025-11-17 on ClinicalTrials.gov
What's tested:PLAY Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
System Usability Scale
Measured over 3 months post-enrollment
+4 more outcomes measured
Childhood Cancer
1 sites across 1 states
Ohio1

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Eligibility criteria

Exclusion

Has a documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)
Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)
Treated for a benign tumor
  • System Usability Scale3 months post-enrollment

    This is a 10-item measure that will quantitatively assess usability of our web-based program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of \>68% (above average).

  • Intervention Appropriateness Measure (IAM)3 Months Post-Enrollment

    Participants will use this four-item measure to rate the appropriateness of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more appropriate, an overall score of 4 or higher (80%) means a participant found the program to be appropriate.

  • Acceptability of Intervention Measure (AIM)3 Months Post-Enrollment

    This is a four-item measure that will have participants rate the acceptability of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more acceptable, an overall score of 4 or higher (80%) means a participant found the program to be acceptable.

  • Adapted Website Evaluation Questionnaire (WEQ)3 months post-enrollment

    This measure will assess accessibility and satisfaction with the PLAY Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (\> 80%) are an indication of satisfaction with the PLAY program.

  • Feasibility of the PLAY program3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

    Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%), completion rate (# completing core PLAY sessions/#enrolled; milestone greater than or equal to 75%), retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%); Caregivers who rate the intervention greater than or equal to 80% on the Feasibility Intervention Measure (FIM; milestone \>80%), which is a four-item measure. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.