Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women

NCT ID: NCT02273206

Last Updated: 2020-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost entirely Latino or African American. Cancer is the leading cause of premature death in the Bronx, with morality rates significantly higher than for New York City as a whole. Low-income/minority populations are more likely to be diagnosed with preventable and late-stage cancers than the general population, in part, due to lower screening rates. While research has addressed screening barriers in low-income/minority groups, depression, a common,potentially critical barrier, has received scant attention. Research suggests that depressed women are less likely to engage in cancer screening, especially mammography and Pap testing. The link between mental health and cancer screening is particularly important to address in the Bronx, which has the highest rates of self-reported serious psychological distress (a measure closely related to depression) in New York City. Depression affects almost 1 in 4 minority women, and while minorities often seek help for depression in primary care, primary care depression management often does not meet evidence-based standards. Drawing on the expertise and close collaboration of Bronx medical and social service providers and patient stakeholders, this study will determine whether a collaborative care intervention that addresses both depression and cancer screening needs simultaneously among women ages 50-64 is more effective at improving cancer screening and patient-reported outcomes for women with depression than an existing evidence-based cancer screening intervention alone.

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.

Detailed Description

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Conditions

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Depression Breast Cancer Screening Cervical Cancer Screening Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Prevention Care Management for Cancer Screening

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Prevention Care Management for Depression and Cancer Screening

Intervention Type BEHAVIORAL

Prevention Care Management for Cancer Screening

Intervention Type BEHAVIORAL

Interventions

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Prevention Care Management for Depression and Cancer Screening

Intervention Type BEHAVIORAL

Prevention Care Management for Cancer Screening

Intervention Type BEHAVIORAL

Other Intervention Names

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Collaborative Care Intervention (CCI) Prevention Care Manager (PCM)

Eligibility Criteria

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Inclusion Criteria

* Resident of the Bronx
* Overdue for breast, cervical or colorectal cancer screening
* Screen positive for depression
* No cancer diagnosis within the past six months
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Directors Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Morrissania Diagnostic and Treatment Center

The Bronx, New York, United States

Site Status

Morris Heights Health Center

The Bronx, New York, United States

Site Status

Segundo Ruiz Belvis Diagnostic and Treatment Center

The Bronx, New York, United States

Site Status

BronwWorks

The Bronx, New York, United States

Site Status

Urban Health Plan

The Bronx, New York, United States

Site Status

Montefiore Family Care Center

The Bronx, New York, United States

Site Status

Good Shepherd Service

The Bronx, New York, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 34803050 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IH-12-11-4522

Identifier Type: -

Identifier Source: org_study_id

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