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

NCT ID: NCT00477646

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-02-28

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.

Conditions

Breast Cancer; Cervical Cancer; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Prevention Care Management

Intervention Type: BEHAVIORAL

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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dartmouth Medical School, Department of Community & Family Medicine

Principal Investigators

Allen J. Dietrich, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Clinical Directors Network, Incorporated

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23835819 (View on PubMed)

Other Identifiers

P30CA023108

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DMS-20253

Identifier Type: -

Identifier Source: secondary_id

CDR0000537346

Identifier Type: -

Identifier Source: org_study_id