New York Prevention Care Manager Project
40 Years
69 Years
Female
Breast Cancer, Cervical Cancer, Colorectal Cancer
Trial Information
New York Prevention Care Manager Project
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Screening
Outcome Measure:
Follow-up patient cancer 3 months after completion of study treatment
Safety Issue:
No
Principal Investigator
Allen J. Dietrich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000450797
NCT ID:
NCT00376909
Start Date:
November 2001
Completion Date:
Related Keywords:
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- breast cancer
- cervical cancer
- colon cancer
- rectal cancer
- Breast Neoplasms
- Uterine Cervical Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Clinical Directors Network, Incorporated | New York, New York 10018 |
