Clinical Trials Directory

Trials / Completed

CompletedNCT00477646

Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care

New York Prevention Care Manager Project / Medicaid Managed Care Organization Version

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,241 (actual)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
Female
Age
50 Years – 64 Years
Healthy volunteers
Not accepted

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.

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, Community/Migrant Health Center (C/MHC), 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 (Community/Migrant 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 2,600 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPrevention Care ManagementTelephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.

Timeline

Start date
2007-07-01
Primary completion
2011-02-01
Completion
2011-02-01
First posted
2007-05-24
Last updated
2011-08-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00477646. Inclusion in this directory is not an endorsement.