Clinical trial NCT00477646: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Colorectal Cancer
Keywords: colon cancer
rectal cancer
breast cancer
cervical cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Clinical Directors Network
First posted: 2007-05-24
Enrollment: 2241
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
timeFrame: 18 months
Secondary outcomes:
measure: Percentage of patients UTD for breast and cervical cancer screening
timeFrame: 18 months
measure: Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Directors Network, Incorporated
state: New York
Study officials:
affiliation: Norris Cotton Cancer Center
name: Allen J. Dietrich, MD
role: STUDY_CHAIR
References:
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.