A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Norris Cotton Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376909
First received: September 13, 2006
Last updated: May 9, 2009
Last verified: September 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Cervical Cancer Colorectal Cancer |
Other: educational intervention Other: study of socioeconomic and demographic variables |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Single Blind Primary Purpose: Screening |
| Official Title: | New York Prevention Care Manager Project |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Follow-up patient cancer 3 months after completion of study treatment [ Designated as safety issue: No ]
- Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy [ Designated as safety issue: No ]
| Estimated Enrollment: | 2729 |
| Study Start Date: | November 2001 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376909
Locations
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| Clinical Directors Network, Incorporated | |
| New York, New York, United States, 10018 | |
Sponsors and Collaborators
Norris Cotton Cancer Center
Investigators
| Principal Investigator: | Allen J. Dietrich, MD | Norris Cotton Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00376909 History of Changes |
| Other Study ID Numbers: | CDR0000450797, DMS-15524 |
| Study First Received: | September 13, 2006 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
breast cancer cervical cancer colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Uterine Cervical Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013