Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT07117461
Status:
RECRUITING
Last Update Posted:
2025-10-16
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Distress Screening and Referral Program in People With Recently Diagnosed Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant referral rate to mental health services', 'timeFrame': '3 months', 'description': 'To track outcomes of a pilot distress screening and referral program at Jamaica Hospital Medical Center with English- and Spanish-speaking cancer patients (n=50), by assessing referral rate to mental health services.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Tumor Cancer', '24-296', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['Solid Tumor Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "It is recommended that cancer centers screen patients for distress and refer them to mental health services when their distress levels reach a certain level. However, many cancer centers don't have distress screening and referral programs. This study will provide valuable information about one distress screening and referral program and whether it can be helpful for a large and diverse group of cancer patients that includes both English- and Spanish-speaking patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* New solid tumor cancer diagnosis (per EMR)\n* Treated or will be treated at Jamaica Hospital Medical Center (per EMR)\n* Has a NCCN DT score of 0 through 10 (per EMR)\n* Age ≥ 18 years (per EMR or self-report)\n* English- or Spanish preferred language for healthcare (per self-report)\n* Able to provide consent (per completion of consent)\n\nExclusion Criteria:\n\n* In the provider or investigative teams' judgement, cognitively not intact to participate in the study (per EMR or investigative team)"}, 'identificationModule': {'nctId': 'NCT07117461', 'briefTitle': 'A Study of a Distress Screening and Referral Program in People With Recently Diagnosed Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Pilot Distress Screening and Referral Program to Detect Comorbid Psychosocial Distress in NYC Safety Net Hospitals Serving Diverse and Underserved Patients Diagnosed With Cancer', 'orgStudyIdInfo': {'id': '24-296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with a New Solid Tumor Diagnosis', 'description': 'Participants will have a new solid tumor cancer diagnosis.', 'interventionNames': ['Behavioral: NCCN Distress Thermometer']}], 'interventions': [{'name': 'NCCN Distress Thermometer', 'type': 'BEHAVIORAL', 'description': 'A tool used to determine on a number scale the amount of distress for the past week', 'armGroupLabels': ['Participants with a New Solid Tumor Diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11418', 'city': 'Richmond Hill', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ateaya Lima, MD', 'role': 'CONTACT', 'phone': '718-206-6000'}], 'facility': 'Medisys Health Network (Data Collection Only)', 'geoPoint': {'lat': 40.69983, 'lon': -73.83125}}], 'centralContacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'email': 'jutagird@mskcc.org', 'phone': '646-888-8361'}, {'name': 'Francesca Gany, MD', 'role': 'CONTACT', 'email': 'ganyf@mskcc.org', 'phone': '646-888-8054'}], 'overallOfficials': [{'name': 'Devika Jutagir, PhD', '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 beginning 12 months after publication and for up to 36 months post publication. 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'}}}}