Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women
NCT ID: NCT02273206
Last Updated: 2020-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
802 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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To achieve this, the investigators will compare the effectiveness of these two interventions using a randomized controlled trial (RCT). In partnership with six Bronx Federally Qualified Health Centers (FQHCs), the investigators will recruit approximately 800 women ages 50-64 who screen positive for depression and are non-adherent with recommended cervical, breast, and/or colorectal cancer screenings. The investigators specific aims are to: 1) compare the impact of the two interventions on patient-reported outcomes, including cancer screening knowledge and attitudes, self-efficacy, depression-related stigma, provider referrals, participation in mental health care, medication adherence, quality of life, satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3) determine whether reducing depression increases the likelihood that low-income women 50-64 will receive cancer screening; 4) determine whether effectiveness of the two interventions in increasing cancer screening varies according to patient characteristics, such as duration of depression, presence of other chronic conditions, and obesity.
This study is designed to increase the investigators understanding of how to enhance primary care systems' ability to improve a range of outcomes related to cancer screening and depression among low-income minority women, and how to best support this population in making cancer-screening decisions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Prevention Care Management for Cancer Screening
The Care Manager will focus on cancer screening, providing education, patient navigation, and motivational support to overcome screening barriers and form favorable attitudes towards screening.
Prevention Care Management for Cancer Screening
Prevention Care Management for Depression and Cancer Screening
The Care Manager will provide depression care management and motivational support (supportive counseling) and act as a critical link between primary care, mental health care provider, and the patients, helping to develop and implement a treatment plan.
In addition, the Care Manager will work with participants on cancer screening, providing education, patient navigation, and motivational support to overcome screening barriers and form favorable attitudes towards screening.
Prevention Care Management for Depression and Cancer Screening
Prevention Care Management for Cancer Screening
Interventions
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Prevention Care Management for Depression and Cancer Screening
Prevention Care Management for Cancer Screening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Overdue for breast, cervical or colorectal cancer screening
* Screen positive for depression
* No cancer diagnosis within the past six months
50 Years
64 Years
FEMALE
No
Sponsors
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Clinical Directors Network
NETWORK
Responsible Party
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Principal Investigators
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Elisa Weiss, PhD
Role: PRINCIPAL_INVESTIGATOR
The Leukemia and Lymphoma Society
Jonathan N Tobin, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Directors Nework
Andrea Cassells, MPH
Role: STUDY_DIRECTOR
Clinical Directors Network
Locations
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Lincoln Ambulatory Care Practice
The Bronx, New York, United States
Morrissania Diagnostic and Treatment Center
The Bronx, New York, United States
Morris Heights Health Center
The Bronx, New York, United States
Segundo Ruiz Belvis Diagnostic and Treatment Center
The Bronx, New York, United States
BronwWorks
The Bronx, New York, United States
Urban Health Plan
The Bronx, New York, United States
Montefiore Family Care Center
The Bronx, New York, United States
Good Shepherd Service
The Bronx, New York, United States
Countries
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References
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Tobin JN, Cassells A, Weiss E, Lin TJ, Holder T, Carrozzi G, Barsanti F, Morales A, Maling A, Espejo M, Ascher A, Gilbert E, Casiano L, O-Hara-Cicero E, Weed J, Dietrich A. Integrating Cancer Screening and Mental Health Services in Primary Care: Protocol and Baseline Results of a Patient-Centered Outcomes Intervention Study. J Health Care Poor Underserved. 2021;32(4):1907-1934. doi: 10.1353/hpu.2021.0173.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IH-12-11-4522
Identifier Type: -
Identifier Source: org_study_id
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