Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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New York Prevention Care Manager Project / Medicaid Managed Care Organization Version

Conditions
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Breast Cancer, Cervical Cancer, Colorectal Cancer

Intervention / Treatment
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* Behavioral: Prevention Care Management


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Enrolled in a participating Medicaid Managed Care Organization (MMCO) as a Medicaid patient for ≥ 12 months Not up-to-date (UTD) for colorectal cancer screening UTD status defined by any of the following: Home fecal occult blood test within the past 12 months Flexible sigmoidoscopy within the past 5 years Double-contrast barium enema within the past 5 years Colonoscopy within the past 10 years Registered to receive primary care from a participating Community/Migrant Health Center, Diagnostic and Treatment Center, or other participating practice in New York City Must have a telephone available No MMCO claim for any of the following: Colorectal, breast, or cervical cancer Colon polyp removal Total colectomy PATIENT CHARACTERISTICS: Female Able to use telephone No plans to move for ≥ 1 year PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention Care Management<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening | Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients UTD for breast and cervical cancer screening |  | 18 months | 
| Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer, breast cancer, cervical cancer