Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477646
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2007-05-23
Brief Title:
Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
New York Prevention Care Manager Project Medicaid Managed Care Organization Version
Status:
COMPLETED
Status Verified Date:
2011-08
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 Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening including helping them to schedule cancer screening appointments
PURPOSE This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal cervical and breast cancer
PURPOSE This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal cervical and breast cancer
Detailed Description:
OBJECTIVES
Primary
Develop and evaluate an enhanced telephone support intervention Prevention Care Manager PCM to promote colorectal cervical and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization MMCO
Explore the impact of patient CommunityMigrant Health Center CMHC and MMCO characteristics on cancer screening status and the impact of the intervention
Evaluate the impact of the enhanced PCM intervention upon colorectal breast and cervical cancer screening rates
Secondary
Compare the status of women who are up-to-date UTD on CRC screening versus the UTD status of cervical cancer and breast cancer screening
OUTLINE This is a randomized controlled study The study is conducted in 2 parts
Part 1 barrier interview and pilot testing Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year
Barrier interview Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare as well as facilitators which have encouraged them to be screened
Pilot testing Patients from the barrier interviews and other eligible Medicaid Managed Care Organization MMCO patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months
Part 2 randomized control trial Patients are stratified according to treatment center CommunityMigrant health center vs Diagnostic and Treatment Center and age Patient are randomized to 1 of 2 intervention arms
Arm I Prevention Care Manager Patients are stratified according to the number of tests for which they are up-to-date at baseline Patients receive reminder letters encouraging them to contact their primary care provider for colorectal breast and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal breast and cervical cancer screening
Arm II usual care Patients receive usual care according to their primary care physician
In both arms patients are followed for 18 months
PROJECTED ACCRUAL A total of 2600 patients will be accrued for this study
Primary
Develop and evaluate an enhanced telephone support intervention Prevention Care Manager PCM to promote colorectal cervical and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization MMCO
Explore the impact of patient CommunityMigrant Health Center CMHC and MMCO characteristics on cancer screening status and the impact of the intervention
Evaluate the impact of the enhanced PCM intervention upon colorectal breast and cervical cancer screening rates
Secondary
Compare the status of women who are up-to-date UTD on CRC screening versus the UTD status of cervical cancer and breast cancer screening
OUTLINE This is a randomized controlled study The study is conducted in 2 parts
Part 1 barrier interview and pilot testing Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year
Barrier interview Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare as well as facilitators which have encouraged them to be screened
Pilot testing Patients from the barrier interviews and other eligible Medicaid Managed Care Organization MMCO patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months
Part 2 randomized control trial Patients are stratified according to treatment center CommunityMigrant health center vs Diagnostic and Treatment Center and age Patient are randomized to 1 of 2 intervention arms
Arm I Prevention Care Manager Patients are stratified according to the number of tests for which they are up-to-date at baseline Patients receive reminder letters encouraging them to contact their primary care provider for colorectal breast and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal breast and cervical cancer screening
Arm II usual care Patients receive usual care according to their primary care physician
In both arms patients are followed for 18 months
PROJECTED ACCRUAL A total of 2600 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 |
|---|---|---|---|
| P30CA023108 | NIH | None | None |
| DMS-20253 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |