Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

Tracking Information
First Submitted Date  ICMJE September 13, 2006
First Posted Date  ICMJE September 15, 2006
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE November 2001
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2007)
  • Follow-up patient cancer 3 months after completion of study treatment
  • Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
Official Title  ICMJE New York Prevention Care Manager Project
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
Intervention  ICMJE
  • Other: educational intervention
  • Other: study of socioeconomic and demographic variables
Study Arms  ICMJE
  • Experimental: Intervention
    Series of telephone support calls from a trained prevention care manager
    Interventions:
    • Other: educational intervention
    • Other: study of socioeconomic and demographic variables
  • No Intervention: Usual Care
    Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 20, 2007)
2729
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376909
Other Study ID Numbers  ICMJE CDR0000450797
R01CA087776 ( U.S. NIH Grant/Contract )
DMS-15524
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Allen J. Dietrich, MD Norris Cotton Cancer Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP