Preparing for Life and Academics for Young Childhood Cancer Survivors

Официальное название

Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 t

Первичные конечные точки

• System Usability Scale [Срок оценки: 3 months post-enrollment]
• Intervention Appropriateness Measure (IAM) [Срок оценки: 3 Months Post-Enrollment]
• Acceptability of Intervention Measure (AIM) [Срок оценки: 3 Months Post-Enrollment]
• Adapted Website Evaluation Questionnaire (WEQ) [Срок оценки: 3 months post-enrollment]
• Feasibility of the PLAY program [Срок оценки: 3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)]

Вторичные конечные точки (3)

• Play and Alternative Learning Strategies parent-child interaction coding [Срок оценки: Baseline, 3 and 6 month follow up (Phase II)]
• Parenting Stress Index-Short Form [Срок оценки: Baseline, 3 and 6 months post-enrollment (Phase II)]
• Hospital Depression and Anxiety Scale (HADS) [Срок оценки: Baseline, 3 and 6 months post-enrollment (Phase II)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Nationwide Children's Hospital — Columbus

Публикации

• Moscato EL, Darow E, Quach J, M Winning A, Schmidt M, Wade SL, Gerhardt CA, Sezgin E. Usability Testing of an Internet-Based Responsive Parenting Program for Caregivers of Young Survivors of Childhood Cancer Living in Rural and Appalachian Communities: Mixed Methods Study. JMIR Pediatr Parent. 2025 Aug 5;8:e70055. doi: 10.2196/70055. PMID 40764035
• Yao N, Alcala HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence, Early Detection, and Survivorship. J Rural Health. 2017 Sep;33(4):375-381. doi: 10.1111/jrh.12213. Epub 2016 Sep 7. PMID 27602545
• Wochos GC, Semerjian CH, Walsh KS. Differences in parent and teacher rating of everyday executive function in pediatric brain tumor survivors. Clin Neuropsychol. 2014;28(8):1243-57. doi: 10.1080/13854046.2014.971875. Epub 2014 Oct 24. PMID 25343533
• Winter AL, Conklin HM, Tyc VL, Stancel H, Hinds PS, Hudson MM, Kahalley LS. Executive function late effects in survivors of pediatric brain tumors and acute lymphoblastic leukemia. J Clin Exp Neuropsychol. 2014;36(8):818-30. doi: 10.1080/13803395.2014.943695. Epub 2014 Aug 15. PMID 25126830
• Willard VW, Qaddoumi I, Zhang H, Huang L, Russell KM, Brennan R, Wilson MW, Rodriguez-Galindo C, Phipps S. A longitudinal investigation of parenting stress in caregivers of children with retinoblastoma. Pediatr Blood Cancer. 2017 Apr;64(4):10.1002/pbc.26279. doi: 10.1002/pbc.26279. Epub 2016 Nov 3. PMID 27808461
• Willard VW, Gordon ML, Means B, Brennan RC, Conklin HM, Merchant TE, Vinitsky A, Harman JL. Social-Emotional Functioning in Preschool-Aged Children With Cancer: Comparisons Between Children With Brain and Non-CNS Solid Tumors. J Pediatr Psychol. 2021 Aug 11;46(7):790-800. doi: 10.1093/jpepsy/jsab018. PMID 33682007
• Willard VW, Cox LE, Russell KM, Kenney A, Jurbergs N, Molnar AE Jr, Harman JL. Cognitive and Psychosocial Functioning of Preschool-Aged Children with Cancer. J Dev Behav Pediatr. 2017 Oct;38(8):638-645. doi: 10.1097/DBP.0000000000000512. PMID 28937451
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459

Идентификаторы

NCT: NCT06769334 · STUDY00004302 · K08CA290060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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