Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 9:24 AM
Study NCT ID:
NCT06769334
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preparing for Life and Academics for Young Childhood Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Staff members who are completing the coding for the standardized parent-child interaction task will be blinded to time point.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Behavior Rating Inventory of Executive Function (BRIEF-P or -2)', 'timeFrame': 'Baseline, 3 and 6 months post-enrollment (Phase II)', 'description': '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).'}, {'measure': 'Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale)', 'timeFrame': 'Baseline, 3 and 6 months post-enrollment (Phase II)', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'System Usability Scale', 'timeFrame': '3 months post-enrollment', 'description': '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).'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': '3 Months Post-Enrollment', 'description': '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.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': '3 Months Post-Enrollment', 'description': '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.'}, {'measure': 'Adapted Website Evaluation Questionnaire (WEQ)', 'timeFrame': '3 months post-enrollment', 'description': '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.'}, {'measure': 'Feasibility of the PLAY program', 'timeFrame': '3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Play and Alternative Learning Strategies parent-child interaction coding', 'timeFrame': 'Baseline, 3 and 6 month follow up (Phase II)', 'description': '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.'}, {'measure': 'Parenting Stress Index-Short Form', 'timeFrame': 'Baseline, 3 and 6 months post-enrollment (Phase II)', 'description': '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).'}, {'measure': 'Hospital Depression and Anxiety Scale (HADS)', 'timeFrame': 'Baseline, 3 and 6 months post-enrollment (Phase II)', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['positive parenting', 'development', 'school readiness', 'digital health', 'caregiver stress', 'school advocacy'], 'conditions': ['Childhood Cancer']}, 'referencesModule': {'references': [{'pmid': '40764035', 'type': 'BACKGROUND', 'citation': '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': '27602545', 'type': 'BACKGROUND', 'citation': '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': '25343533', 'type': 'BACKGROUND', 'citation': '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': '25126830', 'type': 'BACKGROUND', 'citation': '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': '27808461', 'type': 'BACKGROUND', 'citation': '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': '33682007', 'type': 'BACKGROUND', 'citation': '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': '28937451', 'type': 'BACKGROUND', 'citation': '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. 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Epub 2012 Oct 12.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?\n2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?\n3. Are caregivers of childhood cancer survivors satisfied with the PLAY program?\n4. How can the PLAY program be improved in the future?\n5. Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress?\n\nWhen 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.\n\nCaregivers 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.\n\nCaregivers 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.\n\nThis 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.', 'detailedDescription': '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.\n\nFor 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.\n\nFollowing 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "For the caregiver:\n\n* Caregiver is the legal guardian of the child (e.g., mothers, fathers, grandparents, adoptive parents)\n* Caregiver lives with the child more than 50% of the time\n* Caregiver primary language is English\n* Caregiver lives within 150 miles of Nationwide Children's Hospital\n\nFor the childhood cancer survivor:\n\n* Received treatment for their cancer (e.g., chemotherapy, surgical resection, radiation therapy)\n* Completed cancer treatment or on maintenance therapy only, without evidence of recurrent disease\n* 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\n\nExclusion Criteria for the childhood cancer survivor:\n\n* Has a documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)\n* Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)\n* Treated for a benign tumor\n\nFor the teacher:\n\nClassroom or daycare teacher of the childhood cancer survivor"}, 'identificationModule': {'nctId': 'NCT06769334', 'acronym': 'PLAY', 'briefTitle': 'Preparing for Life and Academics for Young Childhood Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities', 'orgStudyIdInfo': {'id': 'STUDY00004302'}, 'secondaryIdInfos': [{'id': 'K08CA290060', 'link': 'https://reporter.nih.gov/quickSearch/K08CA290060', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preparing for Life and Academics for Young (PLAY) survivors program', '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.', 'interventionNames': ['Other: PLAY Program']}], 'interventions': [{'name': 'PLAY Program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Preparing for Life and Academics for Young (PLAY) survivors program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Moscato Lab Email', 'role': 'CONTACT', 'email': 'moscatolab@nationwidechildrens.org', 'phone': '614-722-4724'}, {'name': 'Emily Moscato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nationwide Children's Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Emily L Moscato, PhD', 'role': 'CONTACT', 'email': 'moscato_lab@nationwidechildrens.org', 'phone': '614-722-4724'}, {'name': 'Cynthia Gerhardt, PhD', 'role': 'CONTACT', 'email': 'cynthia.gerhardt@nationwidechildrens.org'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study-closure.', 'ipdSharing': 'YES', 'description': 'All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emily Moscato', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}