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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477646
• Other study ID #: CDR0000537346
• Secondary ID: P30CA023108DMS-2
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: August 4, 2011
• Start date: July 2007
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2241
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Clinical Directors Network, Incorporated	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Clinical Directors Network, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of patients UTD for breast and cervical cancer screening		18 months	No
Secondary	Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening		18 months	No