Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-16 @ 5:51 PM
Study NCT ID:
NCT02455505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Family Members in Need of Support While Caregiving and After Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to refine the bereavement risk screening tool and its items based on respondent feedback.', 'timeFrame': '1 year', 'description': 'we will obtain family member input on the pre- and post-loss versions of the screening tool; we will obtain input from a separate sample of family members on a revised version of the screening tool that incorporates feedback'}]}, 'conditionsModule': {'keywords': ['Cancer Care and Bereavement', 'Supportive Care', '15-095'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This screening tool will be used to identify significant relations of patients with advanced medical illness or serious hospitalization and family individuals who lost their loved one and who could use professional support in the future. We are interested in enrolling family members or close friends of patients with advanced medical illness as well as family members or close friends who have lost a loved one. Some screening tools to identify family members who might need support do exist, but the investigators are hoping to develop one that is brief and easier for healthcare providers to use. The information learned in this study will help us refine the screening tool. Family member input will be essential in the development of this screening tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from MSK and Calvary Hospital locations (The Bronx, Brooklyn, and Manhattan), which provides hospice and bereavement services to patients suffering from advanced cancer and their families.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* As per self-report, 21 years or older\n* As per self-report, has a domestic partner or spouse, child (minor or adult), sibling (sister or brother), parent or close friend diagnosed with any advanced medical illness or who was recently (2 months) or is currently hospitalized for life-threatening injuries or conditions related to a traumatic incident (e.g., car accident, overdose, assault) OR\n* As per self-report, experienced the recent (within 2 months to 3 years) death of a domestic partner or spouse, child (minor or adult), sibling, parent or close friend.\n* Responds "yes" to the question "Can you understand spoken and written English?\n* Agrees to be audio-taped during the cognitive interview \\[Waves 1 and 2 only\\] \\* For Part 2 only: In the event that the patient dies prior to a consenting pre-loss family member completing the study questionnaires, the family member will be eligible for participation in the post-loss group after at least 2 months have passed after the loss\n\nExclusion Criteria:\n\n* Significant psychiatric or cognitive disturbance sufficient, in the investigators\' judgment, to preclude the completion of the assessment measures or informed consent (i.e., acute psychiatric or neurological symptoms which require individual treatment)\n* Another family member (parent, domestic partner or spouse, sibling, or adult child) has been enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02455505', 'briefTitle': 'Identifying Family Members in Need of Support While Caregiving and After Loss', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Identifying Family Members in Need of Support While Caregiving and After Loss', 'orgStudyIdInfo': {'id': '15-095'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Risk Screening tool & Cognitive Interview', 'interventionNames': ['Behavioral: background questionnaire', 'Behavioral: bereavement risk screening tool']}], 'interventions': [{'name': 'background questionnaire', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Risk Screening tool & Cognitive Interview']}, {'name': 'bereavement risk screening tool', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Risk Screening tool & Cognitive Interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Calvary Hospital', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'William Rosa, PhD, MBE, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Calvary Hospital, Bronx, NY', 'class': 'OTHER'}, {'name': 'The New School for Social Research', 'class': 'OTHER'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}