Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT07106359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Knowledge about LS and its cancer risks, process for seeking genetic services, steps for cancer prevention', 'timeFrame': 'baseline, 1-month and 6-months post-randomization', 'description': 'sum the number of correct answers.'}, {'measure': 'Self-efficacy for pursuing pre-test genetic counseling and testing', 'timeFrame': 'baseline, 1-month and 6-months post-randomization', 'description': 'This is measured on a scale of 0 = "not at all confident" to 100 = "totally confident".'}, {'measure': 'Perceived risk of Lynch syndrome', 'timeFrame': 'baseline, 1-month and 6-months post-randomization', 'description': 'This is measured on a scale of 0 = "definitely will not have LS variants" to 100 = "definitely will have LS variants".'}, {'measure': 'Perceived priority of seeking genetic services for LS', 'timeFrame': 'baseline, 1-month and 6-months post-randomization', 'description': 'This is measured on a scale of 1 = "not important at all", 5 = "extremely important"'}], 'primaryOutcomes': [{'measure': 'Recruitment and retention rates', 'timeFrame': 'recruitment, baseline, 1-month and 6-months post-randomization', 'description': 'record the numbers of probands approached, probands enrolled, probands who provide contact information of at least one potentially eligible relative, relatives approached, enrolled, and completing each phase of the study.'}, {'measure': 'Completeness of assessment data', 'timeFrame': 'baseline, 1-month and 6-months post-randomization', 'description': 'calculate the percentage of complete data for those participants who complete each assessment period.'}, {'measure': 'use of the intervention/EUC materials', 'timeFrame': '1-month post-randomization', 'description': 'assess whether participants read the control pamphlet and the intervention (and complete any exercises in the intervention if applicable) and calculate the proportion of participants who answered "Yes."'}, {'measure': 'attitudes towards the intervention/EUC materials', 'timeFrame': '1-month post-randomization', 'description': 'This is assessed by 4-point Likert-type items (e.g., relevancy of information, tone of message, likelihood of sharing with family; very satisfied/likely to very dissatisfied/unlikely). Frequencies of responses (n (%)) and average scores (mean (SD)) will be calculated for each item.'}, {'measure': 'scheduling and attendance of pre-test genetic counseling and/or genetic testing', 'timeFrame': '6-months post-randomization', 'description': 'record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake and reason for no uptake.'}], 'secondaryOutcomes': [{'measure': 'scheduling and attendance of pre-test genetic counseling and/or genetic testing', 'timeFrame': '1-month post-randomization', 'description': 'record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake and reason for no uptake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cascade Testing', 'Lynch Syndrome', 'Decision Making']}, 'descriptionModule': {'briefSummary': "The randomized controlled pilot trial aims to evaluate and optimize feasibility of the trial methods and intervention and to explore the intervention's preliminary efficacy. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the intervention or enhanced usual care information. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.", 'detailedDescription': 'I will conduct a 2-arm randomized controlled pilot trial. I will recruit 48 relatives at risk of LS and randomize them to the behavioral intervention arm or the enhanced usual care arm (with a control pamphlet). Permuted block randomization will generate random blocks of size 4-8 in REDCap. I will only enroll one relative per family, so there is no need to account for "family" as a variable. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the behavioral intervention to prepare for a fully powered randomized controlled trial. I will also explore the intervention\'s preliminary efficacy. I will record the numbers of recruitment and retention and assess completeness of data. Data will be collected at baseline (pre-randomization; demographics/medical history, psychosocial outcome measures), post-intervention (1-month post-randomization; behavioral and psychosocial outcome measures; use of the control pamphlet and behavioral intervention), and follow-up (6-months post-randomization; behavioral and psychosocial outcome measures) using REDCap. A brief exit interview will be conducted at 6-months post-randomization for participants who complete the study to gather any feedback they have. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Probands must have the following characteristics: 1) English speaking; 2) at least 18 years old; 3) do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening); 4) must have had genetic testing for Lynch syndrome (LS)\n\nParticipants in the clinical trial must have the following characteristics: 1) English-speaking; 2) at least 18 years old; 3) is a blood relative of a patient undergone genetic testing for LS and at risk for LS; 4) have not initiated the process of genetic services for LS; 5) do not have a personal history of a cancer (excluding non-melanoma skin cancer); 6) do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening).'}, 'identificationModule': {'nctId': 'NCT07106359', 'briefTitle': 'Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome', 'orgStudyIdInfo': {'id': 'IRB-300014784'}, 'secondaryIdInfos': [{'id': 'R00CA277584', 'link': 'https://reporter.nih.gov/quickSearch/R00CA277584', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'enhanced usual care', 'description': 'This arm provides a clinical letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.', 'interventionNames': ['Behavioral: control clinical letter']}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'This arm provides a clinical letter with an intervention booklet', 'interventionNames': ['Behavioral: booklet']}], 'interventions': [{'name': 'booklet', 'type': 'BEHAVIORAL', 'description': 'a clinical letter with a booklet for at-risk families highlighting implications of family history, testing motivators, steps for genetic testing, and potential costs.', 'armGroupLabels': ['intervention']}, {'name': 'control clinical letter', 'type': 'BEHAVIORAL', 'description': 'a clinical letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.', 'armGroupLabels': ['enhanced usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'study team', 'role': 'CONTACT', 'email': 'LSResearch@uabmc.edu'}], 'facility': 'UAB', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Haoyang Yan, PhD', 'role': 'CONTACT', 'email': 'haoyangyan@uabmc.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Haoyang Yan', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}