Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
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|ClinicalTrials.gov Identifier: NCT00477646|
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : August 5, 2011
RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments.
PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cervical Cancer Colorectal Cancer||Behavioral: Prevention Care Management||Not Applicable|
- Develop and evaluate an enhanced telephone support intervention (Prevention Care Manager [PCM]) to promote colorectal, cervical, and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization (MMCO).
- Explore the impact of patient, Community/Migrant Health Center (C/MHC), and MMCO characteristics on cancer screening status and the impact of the intervention.
- Evaluate the impact of the enhanced PCM intervention upon colorectal, breast, and cervical cancer screening rates.
- Compare the status of women who are up-to-date (UTD) on CRC screening versus the UTD status of cervical cancer and breast cancer screening.
OUTLINE: This is a randomized, controlled study. The study is conducted in 2 parts.
Part 1 (barrier interview and pilot testing): Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year.
- Barrier interview: Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare, as well as facilitators which have encouraged them to be screened.
- Pilot testing: Patients from the barrier interviews and other eligible Medicaid Managed Care Organization (MMCO) patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months.
Part 2 (randomized control trial): Patients are stratified according to treatment center (Community/Migrant health center vs Diagnostic and Treatment Center) and age. Patient are randomized to 1 of 2 intervention arms.
- Arm I (Prevention Care Manager): Patients are stratified according to the number of tests for which they are up-to-date at baseline. Patients receive reminder letters encouraging them to contact their primary care provider for colorectal, breast, and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal, breast, and cervical cancer screening.
- Arm II (usual care): Patients receive usual care according to their primary care physician.
In both arms, patients are followed for 18 months.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||New York Prevention Care Manager Project / Medicaid Managed Care Organization Version|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: Prevention Care Management
Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening
Behavioral: Prevention Care Management
Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
No Intervention: Usual Care
Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.
- Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening [ Time Frame: 18 months ]Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.
- Percentage of patients UTD for breast and cervical cancer screening [ Time Frame: 18 months ]
- Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477646
|United States, New York|
|Clinical Directors Network, Incorporated|
|New York, New York, United States, 10018|
|Study Chair:||Allen J. Dietrich, MD||Norris Cotton Cancer Center|