We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376909
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


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

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2729 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: New York Prevention Care Manager Project
Study Start Date : November 2001
Actual Primary Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention
Series of telephone support calls from a trained prevention care manager
 Other: educational intervention
Other: study of socioeconomic and demographic variables
No Intervention: Usual Care
Usual care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Follow-up patient cancer 3 months after completion of study treatment
  2. Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376909


Locations
Layout table for location information
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
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Allen J. Dietrich, MD Norris Cotton Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00376909    
Other Study ID Numbers: CDR0000450797
R01CA087776 ( U.S. NIH Grant/Contract )
DMS-15524
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: September 2006
Keywords provided by Dartmouth-Hitchcock Medical Center:
breast cancer
cervical cancer
colon cancer
rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Colorectal Neoplasms
Uterine Cervical Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases