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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376909
First received: September 13, 2006
Last updated: May 9, 2009
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cervical Cancer
Colorectal Cancer
Other: educational intervention
Other: study of socioeconomic and demographic variables
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Screening
Official Title: New York Prevention Care Manager Project

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Follow-up patient cancer 3 months after completion of study treatment [ Designated as safety issue: No ]
  • Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy [ Designated as safety issue: No ]

Estimated Enrollment: 2729
Study Start Date: November 2001
Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376909

Locations
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
Sponsors and Collaborators
Norris Cotton Cancer Center
Investigators
Principal Investigator: Allen J. Dietrich, MD Norris Cotton Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00376909     History of Changes
Other Study ID Numbers: CDR0000450797, DMS-15524
Study First Received: September 13, 2006
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
cervical cancer
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Uterine Cervical Neoplasms
Breast Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014