- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629993
Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aims of this proposal are:
- To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician cervical cancer screening at 3- and 6-months post-randomization, compared to the rate observed in a service-as-usual control.
- To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of cervical cancer screening guidelines to different physician subgroups.
- To conduct a cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the cervical cancer intervention implemented in physicians' offices.
The long-term goal of this project therefore is to reduce cervical cancer risks among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10027
- Columbia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed
Exclusion Criteria:
- Exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multi-component Academic Detailing
Multi-component, academic detailing regarding ACS guidelines on cervical cancer screening approaches. Includes an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients. |
It will involve multiple intervention components, some of which are standardized across physicians (i.e., self learning packets, post-tests for CME credit, CD-ROMS, videos, newsletters, culturally sensitive patient education materials, office staff informational sessions, chart and patient reminders, and a general office routine for cervical cancer counseling, including performance feedback, as well as media-ready materials).
Academic detailing and the specific office routines will be customized to each physician, although the frequency of the detailing visits will be routinized across all participants, to reduce cost and to maximize its potential for dissemination.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of asymptomatic female patients age 18-85 who receive or are referred for a recto-pelvic bimanual examination with the collection of the Pap smear (per ACS guidelines); collected via medical chart review
Time Frame: 12-month followup
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12-month followup
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
Time Frame: 12-month followup
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12-month followup
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sherri Sheinfeld Gorin, PhD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA9722
- U57/CCU224079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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National Cancer Institute (NCI)Gynecologic Oncology Group; NCIC Clinical Trials GroupTerminatedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Cervical Adenosquamous Cell CarcinomaUnited States, Canada
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