A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women

Dartmouth Health

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Cervical Cancer; Colorectal Cancer

Treatments: Other: educational intervention; Other: study of socioeconomic and demographic variables

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00376909

DMS-15524

R01CA087776 (U.S. NIH Grant/Contract)

CDR0000450797

Details and patient eligibility

About

RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates.

PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

Full description

OBJECTIVES:

• Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women.
• Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area.
• Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy).
• Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only).
• Develop and implement the PCM intervention to help patients overcome barriers.
• Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.

OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center.

• Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.

• Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.

• Part 3: Patients are randomized to 1 of 2 intervention arms.

  • Arm I: Patients are offered health education and follow-up services by telephone with a PCM.
  • Arm II: Patients receive usual care.

PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for pilot study) patients will be accrued for this study.

Enrollment: 2,729 estimated patients

Sex: Female

Ages: 40 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Patients enrolled in the Prevention Care Manager (PCM) controlled, randomized clinical trial (RCT) must meet the following criteria:

  • Registered to receive care at a participating Community Health Center for at least 6 months

  • Overdue for at least one cancer screening as per the following time periods:

    • No mammography within the past 12 months
    • No Pap test within the past 12 months
    • No home fecal occult blood test within the past 12 months
    • No sigmoidoscopy within the past 5 years
    • No colonoscopy within the past 10 years

  • Must not plan to move out of area or change Community Health Center within 15 months

  • No unresolved, urgent abnormal cancer screening result found in medical record

• Patients enrolled in the PCM dissemination pilot study through Affinity Health Plan must meet the following criteria:

  • Enrolled with Affinity Health Plan for at least 12 months

  • Overdue for at least one cancer screening as per the following time periods:

    • No mammography within the past 2 years
    • No Pap test within the past 3 years
    • No home fecal occult blood test within the past year for women ≥ 50 years old
    • No sigmoidoscopy within the past 5 years
    • No colonoscopy within the past 10 years

  • Must have received care at 1 of 6 participating Community Health Centers in New York City

PATIENT CHARACTERISTICS:

• Female
• Must not be in acute distress or have an acute illness
• Age 50 to 69 years for controlled study patients
• Age 40 to 69 years for pilot study patients

PRIOR CONCURRENT THERAPY:

• No concurrent chemotherapy or radiotherapy
• No concurrent active cancer treatment
• No concurrent palliative care

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,729 participants in 2 patient groups

Intervention

Experimental group

Description:

Series of telephone support calls from a trained prevention care manager

Treatment:

Other: educational intervention

Other: study of socioeconomic and demographic variables

Usual Care

No Intervention group

Description:

Usual care