Overview
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:
- Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
- Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
- Are caregivers of childhood cancer survivors satisfied with the PLAY program?
- 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.
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.
Eligibility
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