Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-04 @ 2:14 AM
Study NCT ID:
NCT02713334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 495}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02-25'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The investigators will assess patients' emotional responses to receiving their secondary findings", 'timeFrame': '1 year', 'description': "Through quantitative (i.e., survey) assessments, the investigators will assess patients' emotional (both positive and negative) responses to receiving their secondary findings, and their perceptions regarding the utility of this information and communicating it to family."}]}, 'conditionsModule': {'keywords': ['Decision Making', 'Communication', '16-080'], 'conditions': ['Tumor Genomic Profiling']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "The objective of this protocol is to characterize cancer patients' responses to learning their secondary findings arising from tumor genomic profiling, and the process and outcomes of their decisions to communicate these results to their families.", 'detailedDescription': 'For Phase 1 of this study, the investigators will conduct a prospective, observational study with cancer patients undergoing tumor genomic profiling (n = 300) and their family members (anticipated n ≈ 150). Data collection will occur through an embedded mixed methods design, in which both quantitative (i.e., survey) and qualitative (i.e., semi-structured interview) data are collected at the same timepoint in order to obtain a more complete understanding of specific processes and outcomes.\n\nThey will be recruited from those who already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.\n\nFor Phase 2 of this study, participants (n=500) who have received pathogenic secondary findings through protocol #12-245 will be recruited.\n\nFor Phase 3, efforts will be expanded from the adult populations explored in the preceding phases to the experiences of patients affected by pediatric cancers and their families. Cross-sectional mixed methods data from AYA survivors of pediatric cancers (n=50) and adult caregivers of survivors of pediatric cancer (n=50) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 participants for the proposed study from those already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients (Phase I):\n\n* 18 years of age or older\n* Has consented to MSK IRB protocol #12-245, Consent A and Part C\n* Has not received secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or patient report\n* Diagnosed with a solid tumor as per EMR and/or clinician judgment\n* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.\n\nFamily members (Phase I):\n\n* 18 years of age or older as per self report\n* Nominated by the patient participant as a family member with whom the secondary findings have been shared (spouses/partners are eligible as "family members" for the purposes of this study)\n* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.\n\nPatients (Phase 2):\n\n* 18 years of age of older\n* Has consented to MSK IRB protocol #12-245, Consent Part A and C\n* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefor, participants must be able to communicate in English to complete the surveys.\n\nAYA Survivors of Pediatric Cancers (Phase 3):\n\n* Age 15 to 30 years old\n* Are at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)\n* Has consented or provided assent to MSK IRB protocol #12-245, Consent Part A and C\n* Has received pathogenic secondary findings as a result of MSK IRB protocol #12- 245, Consent Part C as per EMR and/or CGS care provider report\n* Participated in a CGS consultation following receipt of secondary findings\n* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.\n\nAdult Caregivers of Survivors of Pediatric Cancers (Phase 3):\n\n* 18 years of age or older\n* Are the caregiver of a child who was treated for pediatric cancer (i.e., any cancer diagnosed before age 18). Caregiver status is based on either: 1) nomination as such by a young adult survivor (i.e., age 18+), 2) having consented on behalf of a minor child (i.e., age \\<18) to MSK IRB protocol\n\n #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child, or 3) nomination by the adult who consented on behalf of a minor child (i.e., age \\<18) to MSK IRB protocol #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child\n* That child is currently alive and at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)\n* Has consented on behalf of that child, or that child consented, to MSK IRB protocol #12-245, Consent Part A and C\n* That child received pathogenic secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or CGS healthcare provider report\n* Participated in a CGS consultation following receipt of secondary findings\n* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys\n\nExclusion Criteria:\n\n* Received genetic testing in the past that resulted in a pathogenic finding or a variant of unknown significance as reported in the EMR.\n* Major psychiatric illness or cognitive impairment that in the judgment of the investigator or study staff would preclude study participation\n* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.'}, 'identificationModule': {'nctId': 'NCT02713334', 'briefTitle': 'Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling', 'orgStudyIdInfo': {'id': '16-080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'BEHAVIORAL'}, {'name': 'semi-structured interview', 'type': 'BEHAVIORAL'}]}, '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}}], 'overallOfficials': [{'name': 'Jada Hamiliton, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}