Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 9:06 AM
Study NCT ID:
NCT04066361
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPTimizing Treatment Focused Genetic Testing IN Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurement of genetic testing uptake', 'timeFrame': '2 years', 'description': 'The proportion of participants who consent to genetic testing in each study arm'}, {'measure': 'Meaningful cancer treatment changes', 'timeFrame': '2 years', 'description': 'Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.'}, {'measure': 'Satisfaction with pre-genetic test education', 'timeFrame': 'at time of post-counseling/video pre-result disclosure, on average 3 weeks', 'description': 'A validated survey of participants\' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly".'}], 'secondaryOutcomes': [{'measure': 'Communication of results with family members', 'timeFrame': '4 months post-result disclosure', 'description': 'For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.'}, {'measure': 'Intent to disclose genetic test results', 'timeFrame': '1 day (at time of intervention)', 'description': "Three items will assess participants' intentions to disclose genetic testing results"}, {'measure': 'Cascade testing of family members', 'timeFrame': '6 month post-result disclosure', 'description': "This will evaluate participant's discussions about genetic testing within the family for an understanding of how genetic testing information was communicated"}, {'measure': 'Decisional regret', 'timeFrame': '4 months post-result disclosure', 'description': '5 items will be asked pertaining to reflecting on the decision of the participant about getting genetic testing after learning about their result.'}, {'measure': 'Knowledge of multi-gene panel testing', 'timeFrame': '1 day (at the time of intervention)', 'description': "A 6 item survey evaluating participant's understanding of inherited genetic risk"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Other Cancer'], 'conditions': ['Breast Cancer', 'Ovarian Cancer', 'Pancreatic Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.', 'detailedDescription': "In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.\n\nThe first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.\n\nThe Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.\n\nThe second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.\n\nIn both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.\n\nOther studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.\n\nThe investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over the age of 18\n* With a diagnosis of advanced cancer (defined as Stage 3 or 4), or\n* Any stage for pancreatic cancer and\n* No prior cancer genetic panel testing\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women (if known at the time of participation)\n* Prisoners\n* Non-English speakers'}, 'identificationModule': {'nctId': 'NCT04066361', 'acronym': 'OPT-IN', 'briefTitle': 'OPTimizing Treatment Focused Genetic Testing IN Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN', 'orgStudyIdInfo': {'id': '19-068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chatbot', 'description': '* Participant is given a pamphlet introducing genetic testing\n* Participant is given information utilized for clinical, standard of care testing.\n* Will receive genetic information with a virtual interactive Chatbot prior to genetic testing. After the Chatbot education, participant is asked if they would like to proceed with genetic testing.\n* Participant is asked to complete an electronic family history tool', 'interventionNames': ['Other: Chatbot']}, {'type': 'EXPERIMENTAL', 'label': 'Video Education', 'description': '* Participant is given a pamphlet introducing genetic testing\n* Participant is given information utilized for clinical, standard of care testing.\n* Participant will watch a brief educational video that is approximately 8 minutes in length about the genetic testing process and what to expect prior to genetic testing. After the video education, participant is asked if they would like to proceed with genetic testing.\n* Participant is asked to complete an electronic family history tool', 'interventionNames': ['Other: Video Education']}], 'interventions': [{'name': 'Chatbot', 'type': 'OTHER', 'description': 'Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit', 'armGroupLabels': ['Chatbot']}, {'name': 'Video Education', 'type': 'OTHER', 'description': 'Brief video designed to mirror the educational components of a traditional genetic counseling visit', 'armGroupLabels': ['Video Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Huma Q Rana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'url': 'http://innovation@dfci.harvard.edu', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research', 'accessCriteria': 'DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huma Rana, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}