Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05929820
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2023-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Protect Your Colon™ on CRC Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of completion of a CRC screening test', 'timeFrame': '6 months post visit', 'description': "Uptake of CRC screening within 6 months of patients' initial visit"}], 'secondaryOutcomes': [{'measure': 'Qualitative feedback on details of CRC screening test', 'timeFrame': '1 day post visit', 'description': "Completion of questionnaire that looks at:\n\n* Whether CRC screening discussions took place during the visit\n* What specific CRC screening tests were discussed during the visit\n* Patient's intent to complete CRC screening\n* Patient's perceptions on feeling informed about the alternatives, benefits, and risks of the different screening options as well as their clarity on their personal values\n* Patient's assessment of shared decision making on CRC screening\n* Intervention patients' assessment of the usefulness of Protect Your Colon™"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decision aid', 'Stool test', 'Colonoscopy', 'CT scan'], 'conditions': ['Colorectal Cancer Screening']}, 'descriptionModule': {'briefSummary': "The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 45 to 75 years old\n* No prior CRC screening or not up-to-date with CRC screening\n* Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)\n* No prior colon polyps\n* Additional inclusion criteria for participants recruited through Cint online survey panels: (i) appointment with a primary care provider up to 6 weeks from time of screening, and (ii) have Preferred Provider Organization (PPO) insurance.\n\nExclusion Criteria:\n\n* Does not speak English\n* Does not have internet access\n* Any records flagged "break the glass" or "research opt out."'}, 'identificationModule': {'nctId': 'NCT05929820', 'briefTitle': 'Impact of Protect Your Colon™ on CRC Screening', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors', 'orgStudyIdInfo': {'id': 'STUDY2402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protect Your Colon™ (Intervention)', 'description': 'Patients randomized to Protect Your Colon™ will be directed to go through the website before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.', 'interventionNames': ['Behavioral: Protect Your Colon™']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care (Control)', 'description': "The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment."}], 'interventions': [{'name': 'Protect Your Colon™', 'type': 'BEHAVIORAL', 'description': "Protect Your Colon™ is an online decision aid focused on CRC screening. The site will first educate patients on the importance of CRC screening and offer information on the advantages and disadvantages of the available test options. Protect Your Colon™ will then present an interactive conjoint analysis-a quantitative survey technique that elucidates how individuals make complex decisions-to precisely determine individuals' latent preferences regarding CRC screening options. Afterwards, the app will generate a personalized report that rank orders the importance of each test attribute (e.g., accuracy, invasiveness, test frequency) in patients' decision making and identifies the screening modality that best matches their preferences. The report will also be shareable with physicians, enabling patients and providers to engage in shared decision making surrounding CRC screening in the clinic.", 'armGroupLabels': ['Protect Your Colon™ (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antwon Chaplin, BA', 'role': 'CONTACT', 'email': 'Antwon.Chaplin@cshs.org', 'phone': '310.248.6790'}, {'name': 'Christopher V Almario, MD, MSHPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Christopher V Almario, MD, MSHPM', 'role': 'CONTACT', 'email': 'Christopher.Almario@csmc.edu', 'phone': '310.423.4462'}, {'name': 'Muskaan R Mehra, MS', 'role': 'CONTACT', 'email': 'muskaan.mehra@cshs.org', 'phone': '310.423.0715'}], 'overallOfficials': [{'name': 'Christopher V Almario, MD, MSHPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available after study completion and for up to 3 years after study completion.', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.', 'accessCriteria': 'The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christopher Almario', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}