Preparing for Life and Academics for Young Childhood Cancer Survivors
NCT ID: NCT06769334
Last Updated: 2025-11-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
105 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-12-12
Study Completion Date
2026-12-01
Brief Summary
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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.
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.
Detailed Description
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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.
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.
Conditions
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Childhood Cancer
Keywords
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positive parenting
development
school readiness
digital health
caregiver stress
school advocacy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Staff members who are completing the coding for the standardized parent-child interaction task will be blinded to time point.
Study Groups
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Preparing for Life and Academics for Young (PLAY) survivors program
PLAY is a digital health intervention involving 7 self-directed web-modules and up to 10 virtual coaching sessions conducted weekly to biweekly (7 paired plus up to 3 booster sessions) for caregivers of young childhood cancer survivors (3-6 years). The module content focuses on psychoeducation and positive parenting skills and the coaching focuses on live practice of positive parenting skills.
Group Type
EXPERIMENTAL
PLAY Program
Intervention Type
OTHER
The PLAY Program is a web-based program created for caregivers of childhood cancer survivors. The program consists of seven modules with the following topics: 1) Introduction to the program 2) Self-Care 3) Relationships 4) Getting Ready for School 5) Talking, Reading, and Counting together 6) Social and Emotional Development 7) Review Module. The program is meant to be completed over approximately three months, and caregivers in the program will meet with a coach on a weekly or bi-weekly basis to discuss what they learned in the modules and how to practice it in their daily lives.
Interventions
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PLAY Program
The PLAY Program is a web-based program created for caregivers of childhood cancer survivors. The program consists of seven modules with the following topics: 1) Introduction to the program 2) Self-Care 3) Relationships 4) Getting Ready for School 5) Talking, Reading, and Counting together 6) Social and Emotional Development 7) Review Module. The program is meant to be completed over approximately three months, and caregivers in the program will meet with a coach on a weekly or bi-weekly basis to discuss what they learned in the modules and how to practice it in their daily lives.
Intervention Type
OTHER
Eligibility Criteria
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Exclusion Criteria
* 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
For the teacher:
Classroom or daycare teacher of the childhood cancer survivor
* Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)
* Treated for a benign tumor
For the teacher:
Classroom or daycare teacher of the childhood cancer survivor
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Nationwide Children's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Emily Moscato
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Moscato Lab Email
Role: primary
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00004302
Identifier Type: -
Identifier Source: org_study_id