Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT07293520
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Consent Experiences in Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004591', 'term': 'Electrophoresis, Polyacrylamide Gel'}], 'ancestors': [{'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's knowledge of consent", 'timeFrame': 'Time of consent completion for parent study (day 1)', 'description': "Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests."}, {'measure': "Patient's anxiety about enrolling", 'timeFrame': 'Time of consent completion for parent study (day 1)', 'description': "Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests."}], 'secondaryOutcomes': [{'measure': "Patient's trust in information", 'timeFrame': 'Time of consent completion for parent study (day 1)', 'description': "Patient's trust in information will be measured by a single-item on the patient consent experience survey adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The item is a 5-point scale with answers as follows: Not at all, Slightly, Moderately, Very, and Extremely. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests."}, {'measure': "Patient's perceptions of patient centered care", 'timeFrame': 'Time of consent completion for parent study (day 1)', 'description': 'Perception of patient-centered care (PCC) will be measured by three items on the patient consent experience survey which are adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The items are a 4-point scale as follows: Always, Usually, Sometimes, and Never. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests.'}, {'measure': 'Parent study enrollment rates', 'timeFrame': 'Completion of enrollment (estimated total time is 9-13 months)', 'description': 'Enrollment rates will be measured by total number of patients enrolled in each parent study. Responses will be reported via descriptive statistics and between group differences will be examined via t-tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Informed Consent', 'Key information', 'Research Ethics'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': "This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Eligibility Criteria:\n\n* Patient must be 18 years or older\n* Patients must be English-speaking\n* Able to understand an IRB-approved written consent document\n* Must go through the consent process for one of the parent studies\n\nResearch Team Eligibility Criteria:\n\n* Member of a parent study research team\n* Engaged in the study consent processes, including creating and reviewing consents or enrolling participants'}, 'identificationModule': {'nctId': 'NCT07293520', 'briefTitle': 'Improving Consent Experiences in Clinical Trials', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Improving Consent Experiences in Clinical Trials at Siteman Cancer Center', 'orgStudyIdInfo': {'id': '202511065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard consent forms', 'description': 'The approved standard consent form will be used during the consent processes.', 'interventionNames': ['Behavioral: Standard Consent Form']}, {'type': 'EXPERIMENTAL', 'label': 'Standard consent forms with a visual key information (VKI) page', 'description': 'The approved standard consent form with a VKI page will be used during the consent processes.', 'interventionNames': ['Behavioral: Standard Consent Form', 'Behavioral: Visual Key Information (VKI) page']}, {'type': 'EXPERIMENTAL', 'label': 'Research Team Members', 'description': "Members of the parent study's research team will complete the research team survey to assess opinions on consent process.", 'interventionNames': ['Behavioral: Standard Consent Form', 'Behavioral: Visual Key Information (VKI) page']}], 'interventions': [{'name': 'Standard Consent Form', 'type': 'BEHAVIORAL', 'description': 'The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.', 'armGroupLabels': ['Research Team Members', 'Standard consent forms', 'Standard consent forms with a visual key information (VKI) page']}, {'name': 'Visual Key Information (VKI) page', 'type': 'BEHAVIORAL', 'description': 'A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.', 'armGroupLabels': ['Research Team Members', 'Standard consent forms with a visual key information (VKI) page']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary C Politi, PhD', 'role': 'CONTACT', 'email': 'mpoliti@wustl.edu', 'phone': '314-935-3802'}, {'name': 'Eliana Goldstein', 'role': 'CONTACT', 'email': 'goldsteinelianac@wustl.edu', 'phone': '314-935-7234'}, {'name': 'Mary C Politi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Mary C Politi, PhD', 'role': 'CONTACT', 'email': 'mpoliti@wustl.edu', 'phone': '314-935-3802'}, {'name': 'Eliana Goldstein, MPH', 'role': 'CONTACT', 'email': 'goldsteinelianac@wustl.edu', 'phone': '314-935-7234'}], 'overallOfficials': [{'name': 'Mary C Politi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University in St. Louis School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}