Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT00983866
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHOICES: Understanding Clinical Trials as a Treatment Option
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2009-09-14', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials', 'timeFrame': 'Up to three months after the index oncology visit'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who leave the identification and recruitment process at each step.', 'timeFrame': 'Up to three months after the index oncology visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether having a telephone discussion with a nurse educator about making treatment decisions and participating in a clinical trial increases trial participation.\n\nThe investigators hypothesize that the participants in the intervention group will be more likely to take part in a clinical trial than those in the usual care group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases\n\nExclusion Criteria:\n\n* Patients who meet specific exclusion criteria for designated clinical trials'}, 'identificationModule': {'nctId': 'NCT00983866', 'acronym': 'CHOICES', 'briefTitle': 'CHOICES: Understanding Clinical Trials as a Treatment Option', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Increasing Participation in Cancer Clinical Trials', 'orgStudyIdInfo': {'id': 'CN-04CSomk-02-B'}, 'secondaryIdInfos': [{'id': 'R01CA114543', 'link': 'https://reporter.nih.gov/quickSearch/R01CA114543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Telephone Counseling', 'interventionNames': ['Behavioral: Tailored Telephone Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Trial Recruitment Procedures'}], 'interventions': [{'name': 'Tailored Telephone Counseling', 'type': 'BEHAVIORAL', 'description': "The intervention is comprised of a letter introducing patients to the idea of participating in a clinical trial as a possible treatment option, followed by a telephone call by a nurse educator who describes the clinical trials process and answers any questions patients may have. The nurse educators will use a tailored counseling protocol that will enable them to conduct an assessment of patients' understanding about and interest in clinical trials and tailor messages according to patient health literacy and language. The protocol will consist of both proactive and reactive counseling. The nurse educator will have a general list of topics to cover but will tailor the discussion and information provided to individual patients' questions and desire for particular types of information.", 'armGroupLabels': ['Tailored Telephone Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Lou Fehrenbacher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}