Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Cancer
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- System Usability Scale
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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:
- 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?
- 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.
Detailed Description
This study will occur in two phases. Phase I will involve rapid cycle testing of the intervention and Phase II will be a single-arm trial of the PLAY program. For phase I, 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 up to n=15 families have completed the PLAY program. Following rapid cycle testing, phase II will involve a single-arm trial of PLAY program with up to 20 new families of YCCS to evaluate the refined program's feasibility, acceptability, and proof-of-concept. Caregivers will be recruited and will participate using analogous procedures and measures, as described in Phase I, with the addition of 6-month post-baseline assessments.
Investigators
Emily Moscato
Principal Investigator
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
System Usability Scale
Time Frame: 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).
Intervention Appropriateness Measure (IAM)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 program
Time Frame: 3 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.
Secondary Outcomes
- Play and Alternative Learning Strategies parent-child interaction coding(Baseline, 3 and 6 month follow up (Phase II))
- Parenting Stress Index-Short Form(Baseline, 3 and 6 months post-enrollment (Phase II))
- Hospital Depression and Anxiety Scale (HADS)(Baseline, 3 and 6 months post-enrollment (Phase II))