This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
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? 5. Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress? When the child is transitioning to maintenance phase therapies or is no longer actively in cancer treatment, caregivers will be invited to participate. If they agree to participate, they will complete surveys when they begin the study as well as a videotaped interaction task reading and playing 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 10 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and helping 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. This study will happen over two phases. Participants in Phase I of this study will complete all parts of the study as described above. Participants in Phase II (beginning in winter 2025) will complete all parts of the study as described above and a six month follow up that will involve repeating the similar questionnaires and an additional videotaped interaction with their child. Teachers of children will also take part in Phase II with questionnaires at baseline and 3-months later, after participants have completed the PLAY program.
Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
| Inclusion Criteria | Exclusion Criteria |
|---|---|
|
|
Sponsor: Nationwide Children's Hospital
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.