Clinical trial NCT02273206: Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women
Official title: Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Breast Cancer Screening
Cervical Cancer Screening
Colorectal Cancer Screening
Keywords: Depression
Breast Cancer Screening
Cervical Cancer Screening
Colorectal Cancer Screening
Lead sponsor: Clinical Directors Network
Sponsor class: NETWORK
First posted: 2014-10-23
Enrollment: 802
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status
timeFrame: Baseline - 12 months
measure: Assessment of Colorectal Cancer Screening Up to Date Status After Intervention
timeFrame: Baseline - 12 months
measure: Assessment of Breast Cancer Screening Up to Date Status After Intervention
timeFrame: Baseline - 12 months
measure: Assessment of Cervical Cancer Screening Up to Date Status After Intervention
timeFrame: Baseline - 12 months
measure: Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm
timeFrame: Baseline - 12 months
measure: Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months
timeFrame: Baseline - 6 months
measure: Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months
timeFrame: Baseline - 12 months
measure: Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening
timeFrame: Baseline - 12 months
Secondary outcomes:
measure: Mental Health Care Utilization: Assessed by Patient Report
timeFrame: Baseline, 6 months and 12 months
measure: Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale
timeFrame: Baseline, 6 months and 12 months
measure: Physician Recommendation of Screening/Mental Health Care
timeFrame: Baseline, 6 months and 12 months
measure: Generalized Anxiety Disorder
timeFrame: Baseline, 6 months and 12 months
measure: Medical Outcomes Study Health Survey-Short Form
timeFrame: Baseline, 6 months and 12 months
measure: Breast, Cervical and Colorectal Cancer Screening Attitudes
timeFrame: Baseline, 6 months and 12 months
measure: Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10)
timeFrame: Baseline, 6 months and 12 months
measure: Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10)
timeFrame: 12 months
measure: Devaluation-Discrimination Scale
timeFrame: Baseline and 12 months
measure: Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey
timeFrame: Baseline, 6 months and 12 months
measure: Medication Adherence
timeFrame: Baseline, 6 months and 12 months
measure: Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Ambulatory Care Practice
state: New York
city: Bronx
country: United States
facility: Morrissania Diagnostic and Treatment Center
state: New York
city: Bronx
country: United States
facility: Morris Heights Health Center
state: New York
city: Bronx
country: United States
facility: Segundo Ruiz Belvis Diagnostic and Treatment Center
state: New York
city: Bronx
country: United States
facility: BronwWorks
state: New York
city: Bronx
country: United States
facility: Urban Health Plan
state: New York
city: Bronx
country: United States
facility: Montefiore Family Care Center
state: New York
city: Bronx
country: United States
facility: Good Shepherd Service
state: New York
Study officials:
affiliation: The Leukemia and Lymphoma Society
name: Elisa Weiss, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Nework
name: Jonathan N Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Andrea Cassells, MPH
role: STUDY_DIRECTOR
References:
citation: 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.