A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women - Full Text View

Sponsors and Collaborators:	Norris Cotton Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00376909

Purpose

RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates.

PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

Condition	Intervention	Phase
Breast Cancer Cervical Cancer Colorectal Cancer	Procedure: educational intervention Procedure: study of socioeconomic and demographic variables	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Single Blind, Active Control
Official Title:	New York Prevention Care Manager Project

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

Primary Outcome Measures:

Follow-up patient cancer 3 months after completion of study treatment [ Designated as safety issue: No ]
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy [ Designated as safety issue: No ]

Estimated Enrollment:	2729
Study Start Date:	November 2001

Detailed Description:

OBJECTIVES:

Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women.
Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area.
Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy).
Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only).
Develop and implement the PCM intervention to help patients overcome barriers.
Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.

OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center.

Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.
Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.
Part 3: Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients are offered health education and follow-up services by telephone with a PCM.
- Arm II: Patients receive usual care.

PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for pilot study) patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	40 Years to 69 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Patients enrolled in the Prevention Care Manager (PCM) controlled, randomized clinical trial (RCT) must meet the following criteria:
- Registered to receive care at a participating Community Health Center for at least 6 months
- Overdue for at least one cancer screening as per the following time periods:
  - No mammography within the past 12 months
  - No Pap test within the past 12 months
  - No home fecal occult blood test within the past 12 months
  - No sigmoidoscopy within the past 5 years
  - No colonoscopy within the past 10 years
- Must not plan to move out of area or change Community Health Center within 15 months
- No unresolved, urgent abnormal cancer screening result found in medical record
Patients enrolled in the PCM dissemination pilot study through Affinity Health Plan must meet the following criteria:
- Enrolled with Affinity Health Plan for at least 12 months
- Overdue for at least one cancer screening as per the following time periods:
  - No mammography within the past 2 years
  - No Pap test within the past 3 years
  - No home fecal occult blood test within the past year for women ≥ 50 years old
  - No sigmoidoscopy within the past 5 years
  - No colonoscopy within the past 10 years
- Must have received care at 1 of 6 participating Community Health Centers in New York City

PATIENT CHARACTERISTICS:

Female
Must not be in acute distress or have an acute illness
Age 50 to 69 years for controlled study patients
Age 40 to 69 years for pilot study patients

PRIOR CONCURRENT THERAPY:

No concurrent chemotherapy or radiotherapy
No concurrent active cancer treatment
No concurrent palliative care

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376909

Locations

United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Clinical Directors Network, Incorporated
New York, New York, United States, 10018

Sponsors and Collaborators

Norris Cotton Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

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

Publications of Results:

Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71.

Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an efficacious cancer-screening intervention to women enrolled in a Medicaid managed care organization. Ann Fam Med. 2007 Jul-Aug;5(4):320-7.

Ogedegbe G, Cassells AN, Robinson CM, DuHamel K, Tobin JN, Sox CH, Dietrich AJ. Perceptions of barriers and facilitators of cancer early detection among low-income minority women in community health centers. J Natl Med Assoc. 2005 Feb;97(2):162-70.

Study ID Numbers:	CDR0000450797, DMS-15524
Study First Received:	September 13, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00376909
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer
cervical cancer
colon cancer
rectal 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 15, 2009