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소아암 생존자를 위한 생활 및 학업 준비 (PLAY)

2026년 10월 30일 업데이트: Emily Moscato, Nationwide Children's Hospital

소외된 지역 사회의 어린 시절 암 생존자의 신경 발달 결과를 개선하기 위한 디지털 건강 개입

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

105

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Ohio
      • Columbus, Ohio, 미국, 43205
        • 모병
        • Nationwide Children's Hospital
        • 연락하다:
        • 수석 연구원:
          • Emily Moscato, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
System Usability Scale
기간: 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).

3 months post-enrollment
Intervention Appropriateness Measure (IAM)
기간: 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.

3 Months Post-Enrollment
Acceptability of Intervention Measure (AIM)
기간: 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.

3 Months Post-Enrollment
Adapted Website Evaluation Questionnaire (WEQ)
기간: 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.

3 months post-enrollment
Feasibility of the PLAY program
기간: 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.

3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

2차 결과 측정

결과 측정
측정값 설명
기간
Play and Alternative Learning Strategies parent-child interaction coding
기간: Baseline, 3 and 6 month follow up (Phase II)

Caregivers will record themselves playing with with their child for at least 10 minutes for a measure of observed positive parenting behaviors which will be rated with the standardized Play and Learning Strategies coding scheme by trained raters blinded to timepoint. The coding scheme involves 1 to 5 Likert scale ratings of positive parenting behaviors (i.e., warmth, contingent responsiveness, maintaining, verbal scaffolding, demonstration/physical teaching). Proof of concept will be determined if 8 of 15 caregivers demonstrate improvements by greater than 1 point on observed positive parenting behaviors from baseline.

Baseline, 3 and 6 month follow up (Phase II)
Parenting Stress Index-Short Form
기간: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers will complete the Parenting Stress Inventory, Short Form (PSI-SF), yielding a Total Parenting Stress Score. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of parenting stress or reduction to non-clinical levels post-intervention (i.e., Total Parenting Stress < 85th percentile).

Baseline, 3 and 6 months post-enrollment (Phase II)
Hospital Depression and Anxiety Scale (HADS)
기간: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers will complete the Hospital Anxiety and Depression Scale (HADS) which yields Anxiety and Depression Total Scores. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of anxiety/depression or reduction to non-clinical levels post-intervention (i.e., HADS scores less than a score of 8).

Baseline, 3 and 6 months post-enrollment (Phase II)

기타 결과 측정

결과 측정
측정값 설명
기간
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
기간: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers and teachers will complete the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P; ages 2 to 5 years) or the BRIEF-2 (ages 5 years+), yielding a General Executive Composite. Proof of concept will be determined if 8 of 15 caregivers and teachers report either that the child has maintained non-clinical levels of executive functioning problems or has reduced executive functioning problems to the non-clinical range post-intervention (i.e., General Executive Composite T-score less than or equal to 65).

Baseline, 3 and 6 months post-enrollment (Phase II)
Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale)
기간: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers and teachers will also complete the Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale). Proof of concept will be determined if 8 of 15 caregivers and teachers either report that the child has maintained on track performance for pre-academic skills, or has improved in their pre-academic skills to a non-delayed range (i.e., scaled score greater than or equal to 6).

Baseline, 3 and 6 months post-enrollment (Phase II)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 12일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2025년 1월 6일

QC 기준을 충족하는 최초 제출

2025년 1월 6일

처음 게시됨 (실제)

2025년 1월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • STUDY00004302
  • K08CA290060 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.

IPD 공유 기간

IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study-closure.

IPD 공유 액세스 기준

Interested parties will be able to access the IPD by contacting the PI or through request at the Inter-university Consortium for Political and Social Research.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .