Preparing for Life and Academics for Young Childhood Cancer Survivors (PLAY)

Nationwide Children's Hospital

Status: Enrolling

Conditions: Childhood Cancer

Treatments: Other: PLAY Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06769334

K08CA290060 (U.S. NIH Grant/Contract)

STUDY00004302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For the caregiver:

• 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

For the childhood cancer survivor:

• Received treatment for their cancer (e.g., chemotherapy, surgical resection, radiation therapy)
• 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 for the childhood cancer survivor:

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Preparing for Life and Academics for Young (PLAY) survivors program

Experimental group

Description:

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.

Treatment:

Other: PLAY Program