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

Sponsors and Collaborators:	Norris Cotton Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00477646

Purpose

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	Intervention
Breast Cancer Cervical Cancer Colorectal Cancer	Procedure: counseling Procedure: study of socioeconomic and demographic variables

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Active Control
Official Title:	New York Prevention Care Manager Project / Medicaid Managed Care Organization Version

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients UTD for breast and cervical cancer screening [ Designated as safety issue: No ]
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening [ Designated as safety issue: No ]

Estimated Enrollment:	2600
Study Start Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	50 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477646

Locations

United States, New York
Clinical Directors Network, Incorporated	Recruiting
New York, New York, United States, 10018
Contact: Jonathan Tobin, MD 212-382-0699 ext. 234 jntobin@cdnetwork.org

Sponsors and Collaborators

Norris Cotton Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Allen J. Dietrich, MD

Norris Cotton Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000537346, DMS-20253
Study First Received:	May 23, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00477646
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer
breast cancer
cervical cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Skin Diseases
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009