Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
Primary Purpose
Breast Cancer, Cervical Cancer, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Care Management
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring colon cancer, rectal cancer, breast cancer, cervical cancer
Eligibility 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
Sites / Locations
- Clinical Directors Network, Incorporated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prevention Care Management
Usual Care
Arm Description
Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening
Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.
Outcomes
Primary Outcome Measures
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
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
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
Full Information
NCT ID
NCT00477646
First Posted
May 23, 2007
Last Updated
August 4, 2011
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI), Clinical Directors Network
1. Study Identification
Unique Protocol Identification Number
NCT00477646
Brief Title
Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
Official Title
New York Prevention Care Manager Project / Medicaid Managed Care Organization Version
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI), Clinical Directors Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer, Colorectal Cancer
Keywords
colon cancer, rectal cancer, breast cancer, cervical cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevention Care Management
Arm Type
Experimental
Arm Description
Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Care Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
Description
Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Percentage of patients UTD for breast and cervical cancer screening
Time Frame
18 months
Title
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen J. Dietrich, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Directors Network, Incorporated
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23835819
Citation
Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial. Ann Fam Med. 2013 Jul-Aug;11(4):335-43. doi: 10.1370/afm.1469.
Results Reference
derived
Learn more about this trial
Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
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