Preparing for Life and Academics for Young Childhood Cancer Survivors

Not Applicable

Recruiting

• Conditions: Childhood Cancer

• Registration Number: NCT06769334
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions:

1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?

2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?

3. Are caregivers of childhood cancer survivors satisfied with the PLAY program?

4. How can the PLAY program be improved in the future?

When the child is transitioning to maintenance phase therapies or off cancer treatment, caregivers will be invited to participate and complete surveys when they begin the study as well as a videotaped interaction task with their child. Children will complete brief developmental testing at the beginning of the program.

Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 8 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and help their family adjust and cope with stress.

Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program.

Detailed Description

The aim of this study is to refine PLAY to optimize feasibility and acceptability (ORBIT Phase Ib) through rapid-cycle testing with families of YCCS (n=5 per group, up to 15 total) in partnership with advisory boards comprised of 10 families of YCCS, including rural and Appalachian YCCS, and 10 healthcare providers ("co-designers"). Rapid cycle testing to iteratively refine PLAY will determine its optimal timing, dose, and duration until three caregivers sequentially endorse above-average usability (System Usability Scale score \>68), feasibility, and acceptability ratings (\>80%), or n=15 families have completed the PLAY program.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-02-13
• Study Start: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Caregiver is the legal guardian of the child (e.g., mothers, fathers, grandparents, adoptive parents)
• Caregiver lives with the child more than 50% of the time
• Caregiver primary language is English
• Caregiver lives within 150 miles of Nationwide Children's Hospital
• Childhood cancer survivor received treatment for their cancer (e.g., chemotherapy, surgical resection, radiation therapy)
• Childhood cancer survivor completed cancer treatment or on maintenance therapy only, without evidence of recurrent disease
• Childhood cancer survivor is currently between the ages of 3 years old to 6 years old, but no older than 6.5 years old at study enrollment

Exclusion Criteria

• Childhood cancer survivor has documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)
• Childhood cancer survivor did not receive any treatment (e.g., chemotherapy, surgical resection, radiation)
• Childhood cancer survivors was treated for a benign tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
System Usability Scale	3 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) and accessibility and comprehension are rated \>80%.
Appropriateness Measure (AM)	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.
Feasibility of Intervention (FIM)	3 Months Post-Enrollment	This is a four-item measure that will asses the feasibility 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 feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.
Adapted Website Evaluation Questionnaire (WEQ)	3 Months Post-Enrollment	This 31-item measure will assess accessibility and satisfaction with the PLAY Program. 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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States