A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
NCT ID: NCT00376909
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2729 participants
INTERVENTIONAL
2001-11-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Intervention
Series of telephone support calls from a trained prevention care manager
educational intervention
study of socioeconomic and demographic variables
Usual Care
Usual care
No interventions assigned to this group
Interventions
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educational intervention
study of socioeconomic and demographic variables
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
69 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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Allen J. Dietrich, MD
Role: PRINCIPAL_INVESTIGATOR
Norris Cotton Cancer Center
Locations
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Clinical Directors Network, Incorporated
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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DMS-15524
Identifier Type: -
Identifier Source: secondary_id
CDR0000450797
Identifier Type: -
Identifier Source: org_study_id