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Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477646
First Posted: May 24, 2007
Last Update Posted: August 5, 2011
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.
Collaborators:
National Cancer Institute (NCI)
Clinical Directors Network
Information provided by:
Dartmouth-Hitchcock Medical Center
  Purpose

RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments.

PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.


Condition Intervention
Breast Cancer Cervical Cancer Colorectal Cancer Behavioral: Prevention Care Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: New York Prevention Care Manager Project / Medicaid Managed Care Organization Version

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening [ Time Frame: 18 months ]
    Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.


Secondary Outcome Measures:
  • Percentage of patients UTD for breast and cervical cancer screening [ Time Frame: 18 months ]
  • Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening [ Time Frame: 18 months ]

Enrollment: 2241
Study Start Date: July 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevention Care Management
Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening
Behavioral: Prevention Care Management
Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
No Intervention: Usual Care
Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.

Detailed Description:

OBJECTIVES:

Primary

  • Develop and evaluate an enhanced telephone support intervention (Prevention Care Manager [PCM]) to promote colorectal, cervical, and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization (MMCO).
  • Explore the impact of patient, Community/Migrant Health Center (C/MHC), and MMCO characteristics on cancer screening status and the impact of the intervention.
  • Evaluate the impact of the enhanced PCM intervention upon colorectal, breast, and cervical cancer screening rates.

Secondary

  • Compare the status of women who are up-to-date (UTD) on CRC screening versus the UTD status of cervical cancer and breast cancer screening.

OUTLINE: This is a randomized, controlled study. The study is conducted in 2 parts.

  • Part 1 (barrier interview and pilot testing): Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year.

    • Barrier interview: Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare, as well as facilitators which have encouraged them to be screened.
    • Pilot testing: Patients from the barrier interviews and other eligible Medicaid Managed Care Organization (MMCO) patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months.
  • Part 2 (randomized control trial): Patients are stratified according to treatment center (Community/Migrant health center vs Diagnostic and Treatment Center) and age. Patient are randomized to 1 of 2 intervention arms.

    • Arm I (Prevention Care Manager): Patients are stratified according to the number of tests for which they are up-to-date at baseline. Patients receive reminder letters encouraging them to contact their primary care provider for colorectal, breast, and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal, breast, and cervical cancer screening.
    • Arm II (usual care): Patients receive usual care according to their primary care physician.

In both arms, patients are followed for 18 months.

PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study.

  Eligibility

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.


Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled in a participating Medicaid Managed Care Organization (MMCO) as a Medicaid patient for ≥ 12 months
  • Not up-to-date (UTD) for colorectal cancer screening

    • UTD status defined by any of the following:

      • Home fecal occult blood test within the past 12 months
      • Flexible sigmoidoscopy within the past 5 years
      • Double-contrast barium enema within the past 5 years
      • Colonoscopy within the past 10 years
  • Registered to receive primary care from a participating Community/Migrant Health Center, Diagnostic and Treatment Center, or other participating practice in New York City
  • Must have a telephone available
  • No MMCO claim for any of the following:

    • Colorectal, breast, or cervical cancer
    • Colon polyp removal
    • Total colectomy

PATIENT CHARACTERISTICS:

  • Female
  • Able to use telephone
  • No plans to move for ≥ 1 year

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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): NCT00477646


Locations
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)
Clinical Directors Network
Investigators
Study Chair: Allen J. Dietrich, MD Norris Cotton Cancer Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allen J. Dietrich, MD, Dartmouth Medical School, Department of Community & Family Medicine
ClinicalTrials.gov Identifier: NCT00477646     History of Changes
Other Study ID Numbers: CDR0000537346
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-20253
First Submitted: May 23, 2007
First Posted: May 24, 2007
Last Update Posted: August 5, 2011
Last Verified: August 2011

Keywords provided by Dartmouth-Hitchcock Medical Center:
colon cancer
rectal cancer
breast cancer
cervical cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Uterine Cervical 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