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

Breast Cancer Clinical Trial

Official title:

New York Prevention Care Manager Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376909
• Other study ID #: CDR0000450797
• Secondary ID: R01CA087776DMS-1
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2006
• Last updated: November 26, 2014
• Start date: November 2001

Study information

• Verified date: September 2006
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2729
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cervical Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• educational intervention

• study of socioeconomic and demographic variables

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Clinical Directors Network, Incorporated	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up patient cancer 3 months after completion of study treatment			No
Primary	Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy			No