Overview

This trial is active, not recruiting.

Conditions depression, breast cancer screening, cervical cancer screening, colorectal cancer screening
Treatments preventive care management for depression, preventive care management for cancer screening
Sponsor Clinical Directors Network
Start date January 2014
End date December 2017
Trial size 802 participants
Trial identifier NCT02273206, IH-12-11-4522

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 three Bronx Federally Qualified Health Centers (FQHCs), the investigators will recruit approximately 756 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(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.
preventive care management for cancer screening Prevention Care Manager (PCM)
(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.
preventive care management for depression Collaborative Care Intervention (CCI)
preventive care management for cancer screening Prevention Care Manager (PCM)

Primary Outcomes

Measure
Changes from baseline in number of participants with colorectal, breast, and/or cervical cancer screening
time frame: 12 month
Change from Baseline in Patient Health Questionnaire (PHQ)-9 at 6 month
time frame: 6 month
Change from Baseline in Patient Health Questionnaire (PHQ)-9 at 12 month
time frame: 12 month
Change from Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 month
time frame: 6 month
Change from Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 month
time frame: 12 month

Secondary Outcomes

Measure
Mental Health Care Utilization: assessed by chart review and patient report
time frame: 6 month and 12 month
Satisfaction with Decision to Participate in Screening and Mental Health Care as assessed by Decision Scale
time frame: 6 month and 12 month
Physician Recommendation of Screening/mental Health Care
time frame: Baseline, 6 month and 12 month
Generalized Anxiety Disorder
time frame: Baseline, 6 month and 12 month
Medical Outcomes Study Health Survey- Short Form
time frame: Baseline, 6 month and 12 month
Breast, Cervical and Colorectal Cancer Screening attitudes
time frame: Baseline, 6 month and 12 month
Satisfaction with Decision Scale- Cancer screening
time frame: Baseline, 6 month and 12 month
Satisfaction with Decision Scale- Mental Health
time frame: 12 month
Devaluation-Discrimination Scale
time frame: Baseline and 12 month
Ambulatory Care Experiences as assessed by Ambulatory Care Experiences Survey
time frame: Baseline, 6 month and 12 month
Medication Adherence
time frame: Baseline, 6 month and 12 month
Self-efficacy and Behavior towards Cancer Screening/Mental Health Utilization
time frame: Baseline, 6 month and 12 month
Past History of Cancer and Family History of Cancer
time frame: Baseline, 6 month and 12 month
Sociodemographics
time frame: baseline

Eligibility Criteria

Female participants from 50 years up to 64 years old.

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

Additional Information

Official title Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project
Principal investigator Elisa Weiss, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Clinical Directors Network.