Mode
Text Size
Log in / Sign up
N/A N=757 Randomized Supportive Care

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

Depression · Breast Cancer Screening · Cervical Cancer Screening · Colorectal Cancer Screening

Enrolled (actual)
757
Serious AEs
0.1%
Results posted
Mar 2020
Primary outcome: Primary: Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status — 22.0; 26.9; 56.9; 52.8 Percentage (%) of Participants — p=0.2562

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prevention Care Management for Depression and Cancer Screening (Behavioral); Prevention Care Management for Cancer Screening (Behavioral)
Age
Adult · 50+ yrs
Sex
Female
Sponsor
Clinical Directors Network
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status
22.0; 26.9; 56.9; 52.8; 43.9; 42.0 0.2562
PRIMARY
Assessment of Colorectal Cancer Screening Up to Date Status After Intervention
22.0; 26.9; 56.9; 52.8 0.0677
PRIMARY
Assessment of Breast Cancer Screening Up to Date Status After Intervention
43.9; 42.0; 66.7; 66.8 0.8501
PRIMARY
Assessment of Cervical Cancer Screening Up to Date Status After Intervention
42.3; 41.7; 61.6; 64.6 0.4432
PRIMARY
Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm
12.90; 12.96; 8.24; 7.84; 4.60; 5.05 0.39
PRIMARY
Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months
37; 43; 198; 189; 92; 101 0.60
PRIMARY
Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months
37; 43; 198; 189; 92; 101 0.60
PRIMARY
Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening
42.9; 44.1; 71.2; 68.5; 69.2; 72.1 0.4483
SECONDARY
Mental Health Care Utilization: Assessed by Patient Report
162; 165; 216; 214; 116; 136 0.85
SECONDARY
Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale
161; 180; 212; 196; 112; 131 0.20
SECONDARY
Physician Recommendation of Screening/Mental Health Care
298; 282; 80; 96; 281; 284 0.17
SECONDARY
Generalized Anxiety Disorder
79; 79; 114; 108; 89; 95 0.95
SECONDARY
Medical Outcomes Study Health Survey-Short Form
96; 88; 86; 95; 92; 96 0.54
SECONDARY
Breast, Cervical and Colorectal Cancer Screening Attitudes
71; 71; 45; 55; 161; 152 0.74
SECONDARY
Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10)
161; 180; 212; 196; 112; 131
SECONDARY
Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10)
129; 128; 175; 191 0.56
SECONDARY
Devaluation-Discrimination Scale
68; 50; 42; 45; 46; 49 0.18
SECONDARY
Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey
114; 123; 0; 0; 0; 0 0.50
SECONDARY
Medication Adherence
20; 25; 30; 32; 75; 74 0.78
SECONDARY
Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization
98; 87; 87; 98; 90; 87 0.70

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02273206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search