Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376909
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-09-13
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
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
New York Prevention Care Manager Project
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2729 1413 for PCM randomized controlled study and 1316 for pilot study patients will be accrued for this study
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 2729 1413 for PCM randomized controlled study and 1316 for pilot study patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMS-15524 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01CA087776 |
| R01CA087776 | NIH | None | None |