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

New York Prevention Care Manager Project / Medicaid Managed Care Organization Version

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Breast Cancer; Colorectal Cancer
• Intervention / Treatment: Behavioral: Prevention Care Management

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.

• Study Type: Interventional
• Enrollment (Actual): 2241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10018
      • Clinical Directors Network, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients UTD for breast and cervical cancer screening	18 months
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening	18 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI); Clinical Directors Network
• Investigators: Study Chair: Allen J. Dietrich, MD, Norris Cotton Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Estimate): August 5, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: breast cancer; rectal cancer; colon cancer; cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CDR0000537346; P30CA023108 (U.S. NIH Grant/Contract); DMS-20253