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

NCT02273206 | Completed Results

• 1 other identifier: IH-12-11-4522
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 8

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.

Conditions

Depression; Breast Cancer Screening; Cervical Cancer Screening; Colorectal Cancer Screening

Keywords

Depression; Breast Cancer Screening; Cervical Cancer Screening; Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (8)

• Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status

  Comparison of the proportion of patients who were up to date for colorectal cancer, breast cancer and cervical cancer screenings before and after the intervention. (Chart Review)

  Baseline - 12 months

• Assessment of Colorectal Cancer Screening Up to Date Status After Intervention

  Multivariate logistic regression model was used to assess which factors contributed to colorectal cancer screening up to date status.

  Baseline - 12 months

• Assessment of Breast Cancer Screening Up to Date Status After Intervention

  Multivariate logistic regression model was used to assess which factors contributed to breast cancer screening up to date status

  Baseline - 12 months

• Assessment of Cervical Cancer Screening Up to Date Status After Intervention

  Multivariate logistic regression model was used to assess which factors contributed to cervical cancer screening up to date status

  Baseline - 12 months

• Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm

  Comparison of change in depression between the CCI and PCM arm before and after intervention. (Self-Report). The Patient Health Questionnaire-9 (PHQ9) is a well-validated measure of Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for screening and diagnosing depressive episode, assessing severity, and monitoring treatment response. The PHQ9 score ranges from the minimum of 0 (no depression) to the maximum of 27 (severe depression). The detailed PHQ9 scores and corresponding level of depression severity are as follow: 0 (no depression), 1-4 (mild depression), 5-9 (medium-mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression) and 20-27 (severe depression). The mean change in PHQ9 score is the mean of the differences between PHQ9 score at baseline and the PHQ9 score at follow up for all cases in the respective intervention arm; the greater the change in PHQ9 score, the greater the improvement in depression severity.

  Baseline - 12 months

• Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months

  The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations.

  Baseline - 6 months

• Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months

  The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations.

  Baseline - 12 months

• Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening

  Self-Report: We will ask participants about their participation (yes/no) in specific screening methods: Pap testing (past 3 years), mammography (past 2 years), and colorectal screening (fecal occult blood tests (FOBT)/fecal immunohistochemical tests (FIT)), past year; flexible sigmoidoscopy, the past 5 years; and colonoscopy, past 10 years).

  Baseline - 12 months

Secondary Outcomes (12)

• Mental Health Care Utilization: Assessed by Patient Report

  Baseline, 6 months and 12 months

• Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale

  Baseline, 6 months and 12 months

• Physician Recommendation of Screening/Mental Health Care

  Baseline, 6 months and 12 months

• Generalized Anxiety Disorder

  Baseline, 6 months and 12 months

• Medical Outcomes Study Health Survey-Short Form

  Baseline, 6 months and 12 months

Study Arms (2)

Prevention Care Management for Cancer Screening

ACTIVE COMPARATOR

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.

Behavioral: Prevention Care Management for Cancer Screening

Prevention Care Management for Depression and Cancer Screening

EXPERIMENTAL

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.

Behavioral: Prevention Care Management for Depression and Cancer Screening; Behavioral: Prevention Care Management for Cancer Screening

Interventions

Prevention Care Management for Depression and Cancer Screening BEHAVIORAL

Also known as: Collaborative Care Intervention (CCI)

Prevention Care Management for Depression and Cancer Screening

Prevention Care Management for Cancer Screening BEHAVIORAL

Also known as: Prevention Care Manager (PCM)

Prevention Care Management for Cancer Screening; Prevention Care Management for Depression and Cancer Screening

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Clinical Directors Network: lead

Study Sites (8)

Lincoln Ambulatory Care Practice

The Bronx, New York, 10451, United States

Location

Morrissania Diagnostic and Treatment Center

The Bronx, New York, 10452, United States

Location

Morris Heights Health Center

The Bronx, New York, 10453, United States

Location

Segundo Ruiz Belvis Diagnostic and Treatment Center

The Bronx, New York, 10454, United States

Location

BronwWorks

The Bronx, New York, 10456, United States

Location

Urban Health Plan

The Bronx, New York, 10459, United States

Location

Montefiore Family Care Center

The Bronx, New York, 10467, United States

Location

Good Shepherd Service

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• 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.

  PMID: 34803050 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Results Point of Contact

• Title: Andrea Cassells, MPH
• Organization: Clinical Directors Network

acass@cdnetwork.org

212-382-0699

Study Officials

• Elisa Weiss, PhD

  The Leukemia and Lymphoma Society

  PRINCIPAL INVESTIGATOR

• Jonathan N Tobin, PhD

  Clinical Directors Nework

  PRINCIPAL INVESTIGATOR

• Andrea Cassells, MPH

  Clinical Directors Network

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 23, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 12, 2020
• Results First Posted: March 12, 2020

Record last verified: 2020-02

Locations

US (8)