Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
Condition: Breast Cancer; Cervical Cancer; Colorectal Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Prevention Care Management
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: colon cancer; rectal cancer; breast cancer; cervical cancer