Overview

This trial is active, not recruiting.

Conditions breast cancer, cervical cancer, colorectal cancer
Treatments educational intervention, study of socioeconomic and demographic variables
Phase phase 2
Sponsor Norris Cotton Cancer Center
Collaborator National Cancer Institute (NCI)
Start date November 2001
Trial size 2729 participants
Trial identifier NCT00376909, CDR0000450797, DMS-15524

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking single blind
Primary purpose screening

Primary Outcomes

Measure
Follow-up patient cancer 3 months after completion of study treatment
time frame:
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
time frame:

Eligibility Criteria

Female participants from 40 years up to 69 years old.

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

Additional Information

Official title New York Prevention Care Manager Project
Principal investigator Allen J. Dietrich, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).