Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:08 PM
Study NCT ID:
NCT06950008
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant satisfaction with patient navigation (PN) intervention (Feasibility)', 'timeFrame': 'Up to 9 months', 'description': 'Will be measured using previously validated survey questions related to patient navigation interactions. Will be defined as at least 50% of intervention arm participants are "satisfied" or "very satisfied" with the PN intervention. Will be formally assessed using a point estimate and 95% one-sided (score-based) confidence interval.'}, {'measure': 'Demand measures (Feasibility)', 'timeFrame': 'Up to 9 months', 'description': 'Measures the use of the patient navigator (PN). Will check that at least 50% of the sample interacted with the patient navigator for a total of at least 15 minutes.'}, {'measure': 'Implementation of PN intervention (Feasibility)', 'timeFrame': 'Up to 9 months', 'description': 'Number of calls and patient navigator (PN contacts.'}, {'measure': 'Practicality of PN intervention (Feasibility)', 'timeFrame': 'Up to 9 months', 'description': 'Percentage of participants that assess the intervention as appropriate and are willing to recommend it for similar others.'}, {'measure': 'Percentage of recruited individuals who eventually enroll (Feasibility)', 'timeFrame': 'Up to 6 months', 'description': 'Will be tracked to help determine the feasibility of attracting appropriate sample sizes to power a later effectiveness-oriented randomized controlled trial. Recruitment success will be indicated by enrollment of ≥ 20% recruited patients and a total of 75 in 6 months. Point estimates for other key measures will be used as supporting evidence of intervention feasibility.'}, {'measure': 'Risk-management adoption pathway (R-MAP) progress', 'timeFrame': 'Baseline up to 9 months', 'description': 'Will descriptively estimate progress in R-MAP stage for each recommended risk-management action, as well as estimate change in other R-MAP measures between baseline and final surveys. Differences in R-MAP progress and other measures described will be estimated between arms at the final time point. Will regard the intervention as worthy of further effectiveness testing if the difference in R-MAP stage between intervention and control arm participants is ≥ .5 points (on the 6-point measurement scale) and ≥ 15% for at least one risk-management action.'}, {'measure': 'Perceived Breast Cancer Risk', 'timeFrame': 'Up to 9 months', 'description': 'The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized.'}, {'measure': 'Cancer Worry', 'timeFrame': 'Up to 9 months', 'description': 'The percentage of participants with cancer worry indicated by survey responses will be summarized.'}, {'measure': 'Confidence in Coping with Breast Cancer Risk', 'timeFrame': 'Up to 9 months', 'description': 'The percentage of participants with confidence in coping with breast cancer risk indicated by survey responses will be summarized.'}, {'measure': 'Belief that Breast Cancer Risk can be Reduced', 'timeFrame': 'Up to 9 months', 'description': 'The percentage of participants with belief that their breast cancer risk can be reduced indicated by survey responses will be summarized.'}, {'measure': 'Mental Health', 'timeFrame': 'Up to 9 months', 'description': 'Will be assessed via a 5-item inventory at baseline and final surveys.'}, {'measure': 'Information usage (Self-reported)', 'timeFrame': 'Up to 9 months', 'description': 'Self-reported usage of the provided informational websites by the control group will be measured. Number of visits to the informational websites will be summarized.'}, {'measure': 'Information usage (Machine-recorded)', 'timeFrame': 'Up to 9 months', 'description': 'Machine-recorded usage of the provided informational websites by the control group will be measured. Usage will be recorded by tracking the use of the bitly links provided. The number of visits to each informational website will be summarized.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Test the feasibility of the PN intervention and of recruiting participants to a randomized controlled trial of the intervention.\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I: Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.\n\nARM II: Participants receive links to informational websites on breast cancer risk and risk management options on study.\n\nAfter completion of study intervention, participants are followed for up to 1 month.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are non-Hispanic Black or non-Hispanic white\n* Identify as women\n* Are between 18 and 75 years old\n* Have been identified as at potentially high risk by a population-based risk screening program\n* Have never been diagnosed with breast or ovarian cancer\n* Are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (R-MAP) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention\n* Who do not believe cancer can be prevented and/or have not received risk-management guidance from a specialist"}, 'identificationModule': {'nctId': 'NCT06950008', 'briefTitle': 'A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer', 'orgStudyIdInfo': {'id': 'OSU-24198'}, 'secondaryIdInfos': [{'id': 'NCI-2025-01592', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'R21CA271070', 'link': 'https://reporter.nih.gov/quickSearch/R21CA271070', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (informational websites, PN)', 'description': 'Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.', 'interventionNames': ['Other: Educational Intervention', 'Behavioral: Patient Navigation', 'Other: Survey Administration', 'Behavioral: Telephone-Based Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (informational websites)', 'description': 'Participants receive links to informational websites on breast cancer risk and risk management options on study.', 'interventionNames': ['Other: Educational Intervention', 'Other: Survey Administration']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive links to informational websites', 'armGroupLabels': ['Arm I (informational websites, PN)', 'Arm II (informational websites)']}, {'name': 'Patient Navigation', 'type': 'BEHAVIORAL', 'otherNames': ['Patient Navigator Program'], 'description': 'Receive patient navigator phone calls', 'armGroupLabels': ['Arm I (informational websites, PN)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (informational websites, PN)', 'Arm II (informational websites)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive patient navigator phone calls', 'armGroupLabels': ['Arm I (informational websites, PN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tasleem J. Padamsee, PhD', 'role': 'CONTACT', 'email': 'padamsee.1@osu.edu', 'phone': '614-688-0986'}, {'name': 'Tasleem J. Padamsee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State University Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '800-293-5066'}], 'overallOfficials': [{'name': 'Tasleem J Padamsee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tasleem Juana Padamsee', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}