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

New York Prevention Care Manager Project

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Breast Cancer; Colorectal Cancer
• Intervention / Treatment: Other: educational intervention; Other: study of socioeconomic and demographic variables

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2729
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10018
      • Clinical Directors Network, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Series of telephone support calls from a trained prevention care manager	Other: educational intervention; Other: study of socioeconomic and demographic variables
No Intervention: Usual Care; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Follow-up patient cancer 3 months after completion of study treatment
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Allen J. Dietrich, MD, Norris Cotton Cancer Center

Publications and helpful links

General Publications

• Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.
• Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an efficacious cancer-screening intervention to women enrolled in a Medicaid managed care organization. Ann Fam Med. 2007 Jul-Aug;5(4):320-7. doi: 10.1370/afm.701.
• Ogedegbe G, Cassells AN, Robinson CM, DuHamel K, Tobin JN, Sox CH, Dietrich AJ. Perceptions of barriers and facilitators of cancer early detection among low-income minority women in community health centers. J Natl Med Assoc. 2005 Feb;97(2):162-70.

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: September 13, 2006
• First Submitted That Met QC Criteria: September 13, 2006
• First Posted (Estimate): September 15, 2006

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: breast cancer; rectal cancer; colon cancer; cervical cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Cervical Neoplasms; Breast Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000450797; R01CA087776 (U.S. NIH Grant/Contract); DMS-15524