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

Dartmouth Health

Status: Completed

Conditions: Breast Cancer; Cervical Cancer; Colorectal Cancer

Treatments: Behavioral: Prevention Care Management

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00477646

CDR0000537346

DMS-20253

P30CA023108 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,241 patients

Sex: Female

Ages: 50 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,241 participants in 2 patient groups

Prevention Care Management

Experimental group

Description:

Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening

Treatment:

Behavioral: Prevention Care Management

Usual Care

No Intervention group

Description:

Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.