A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
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.
|Breast Cancer Cervical Cancer Colorectal Cancer||Other: educational intervention Other: study of socioeconomic and demographic variables||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
|Official Title:||New York Prevention Care Manager Project|
- Follow-up patient cancer 3 months after completion of study treatment
- Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
|Study Start Date:||November 2001|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
Series of telephone support calls from a trained prevention care manager
|Other: educational intervention Other: study of socioeconomic and demographic variables|
No Intervention: Usual Care
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376909
|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|
|Principal Investigator:||Allen J. Dietrich, MD||Norris Cotton Cancer Center|