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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New York Prevention Care Manager Project

Conditions
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Breast Cancer, Cervical Cancer, Colorectal Cancer

Intervention / Treatment
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* Other: educational intervention
* Other: study of socioeconomic and demographic variables


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Series of telephone support calls from a trained prevention care manager | Other: educational intervention<br> <br> Other: study of socioeconomic and demographic variables<br> <br> |
| No Intervention: Usual Care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, cervical cancer, colon cancer, rectal cancer