Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
This study has been completed.
Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborators:
Clinical Directors Network
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00477646
First received: May 23, 2007
Last updated: August 4, 2011
Last verified: August 2011
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 50 Years to 64 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477646
Locations
| United States, New York | |
| Clinical Directors Network, Incorporated | |
| New York, New York, United States, 10018 | |
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Clinical Directors Network
Investigators
| Study Chair: | Allen J. Dietrich, MD | Norris Cotton Cancer Center |
More Information
Additional Information:
No publications provided
| 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, DMS-20253 |
| Study First Received: | May 23, 2007 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
colon cancer rectal cancer breast cancer cervical cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Uterine Cervical Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013