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

Primary Purpose

Breast Cancer, Cervical Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
educational intervention
study of socioeconomic and demographic variables
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, cervical cancer, colon cancer, rectal cancer

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Clinical Directors Network, Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

Series of telephone support calls from a trained prevention care manager

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2006
Last Updated
November 26, 2014
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00376909
Brief Title
A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
Official Title
New York Prevention Care Manager Project
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer, Colorectal Cancer
Keywords
breast cancer, cervical cancer, colon cancer, rectal cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2729 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Series of telephone support calls from a trained prevention care manager
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Primary Outcome Measure Information:
Title
Follow-up patient cancer 3 months after completion of study treatment
Title
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen J. Dietrich, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Clinical Directors Network, Incorporated
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16618953
Citation
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.
Results Reference
result
PubMed Identifier
17664498
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. doi: 10.1370/afm.701.
Results Reference
result
PubMed Identifier
15712779
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.
Results Reference
result

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

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