Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-05 @ 5:30 PM
Study NCT ID:
NCT07212166
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Questionnaires in Adolescents and Young Adults With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test-retest reliability', 'timeFrame': 'up to one month', 'description': 'The test-retest reliability will be based on the intraclass correlation (ICC) coefficients between the baseline and follow-up domain scores of PRO-AYA.'}, {'measure': 'Linguistically validate PRO-AYA or patients who prefer their healthcare be delivered in Spanish. (Cohort 2)', 'timeFrame': 'up to a month', 'description': 'The primary goal of these cognitive interviews is to ensure that the wording and/or phrasing of the instructions, questions and answer choices are appropriate for native Spanish-speakers. The wording and phrasing are a result of direct translation of the English version of the PRO-AYA to a Spanish version.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults', 'Psychometric and Linguistic Validation'], 'conditions': ['Adolescents and Young Adults With Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English- or Spanish proficient\n\n o As assessed by two items: How well do you speak English? What is your preferred language for healthcare?\n* Diagnosed with the first instance of a cancer or the relapse of a prior cancer between the ages of 15 - 39\n* Able to complete questionnaires by themselves or with assistance\n* ECOG Performance Status (0-4)\n* 3 months from last treatment without plan to initiate any form of cancer-directed treatment in the next 3 months'}, 'identificationModule': {'nctId': 'NCT07212166', 'briefTitle': 'A Study of Questionnaires in Adolescents and Young Adults With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Psychometric and Linguistic Validation of PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults (15-39) With Cancer', 'orgStudyIdInfo': {'id': '25-213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AYAs with cancer who are at least three months post treatment with no additional treatment planned', 'description': 'Complete via REDCap (at enrollment): PRO-AYA (PRO-AYA - Patient-Reported Outcomes for Adolescents and Young Adults), Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics, Complete via REDCap (7-10 days later):\n\nPRO-AYA, Patient-Reported, ECOG PS', 'interventionNames': ['Other: Patient-Reported Outcome Surveys']}, {'label': 'AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish', 'description': 'Round 1 Cognitive Interviews Complete via REDCap: Spanish PRO-AYA, Demographic/Clinical Characteristic, Item modification based on patient feedback, Cohort 2b (n = 10) (AYAs who prefer healthcare delivery in Spanish) Round 2 Cognitive interviews, Complete via REDCap: Revised Spanish PRO-AYA, Demographic/Clinical Characteristics', 'interventionNames': ['Other: Spanish version of PRO-AYA and the cognitive interview']}], 'interventions': [{'name': 'Patient-Reported Outcome Surveys', 'type': 'OTHER', 'description': 'PRO-AYA , Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics', 'armGroupLabels': ['AYAs with cancer who are at least three months post treatment with no additional treatment planned']}, {'name': 'Spanish version of PRO-AYA and the cognitive interview', 'type': 'OTHER', 'description': 'Revised Spanish PRO-AYA, Demographic/Clinical Characteristics', 'armGroupLabels': ['AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent Only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Monmouth (Consent Only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Bergen (Consent Only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Commack (Consent Only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent Only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'phone': '347-798-9227'}], 'facility': 'Memorial Sloan Kettering Nassau (Consent Only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Viswatej Avutu, MD', 'role': 'CONTACT', 'email': 'avutuv@mskcc.org', 'phone': '347-798-9227'}, {'name': 'Thomas Atkinson, PhD', 'role': 'CONTACT', 'phone': '646-888-0089'}], 'overallOfficials': [{'name': 'Viswatej Avutu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}