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New York Prevention Care Manager Project


Phase 2
40 Years
69 Years
Open (Enrolling)
Female
Breast Cancer, Cervical Cancer, Colorectal Cancer

Thank you

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 CenterLebanon, New Hampshire  03756-0002
Clinical Directors Network, IncorporatedNew York, New York  10018