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

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Behavioral: Prevention Care Management for Depression and Cancer Screening
* Behavioral: Prevention Care Management for Cancer Screening


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevention Care Management for Cancer Screening<br>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<br> <br> * Other names: Prevention Care Manager (PCM);|
| Experimental: Prevention Care Management for Depression and Cancer Screening<br>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<br> <br> * Other names: Collaborative Care Intervention (CCI);Behavioral: Prevention Care Management for Cancer Screening<br> <br> * Other names: Prevention Care Manager (PCM);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Care Utilization: Assessed by Patient Report | Participants were asked how many times in the past six months they had seen a provider to talk about or to receive medication for feeling sad, nervous, hopeless, or blue. This question was adapted from the NCI's HINTS survey. Two categories were created using the median as a cut point. The two categories were high utilization and low utilization. | Baseline, 6 months and 12 months | 
| Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale | The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to receive treatment for emotional or mental health and to have cervical, breast, and colon cancer screening.The continuous summary score was converted into two categories using the median as a cut point. The two categories are high satisfaction and low satisfaction. | Baseline, 6 months and 12 months | 
| Physician Recommendation of Screening/Mental Health Care | This questionnaire, adopted from National Cancer Institute's (NCI) Health Information National Trends Survey (HINTS), assesses whether patients report that their primary care physician 1) has recommended cervical, breast, and colon cancer screening and 2) has recommended that the patient make an appointment with a mental health provider and/or take psychotropic medication. Two categories were created according to whether the patient received a physician recommendation (yes/no). The category of Recommendation for when they received a recommendation and a category of No Recommendation if they did not receive a recommendation | Baseline, 6 months and 12 months | 
| Generalized Anxiety Disorder | This Generalized Anxiety Disorder scale is based on diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) and measures probable anxiety disorder and severity of anxiety symptoms. Patients are asked to rate how often they have been bothered by 7 problems in the last 2 weeks on a 4-point scale. Standard cut points were used for the Generalized Anxiety Disorder measure. Minimal anxiety is (0-4). Mild Anxiety would be count as (5-9). Moderate Anxiety (10-14) and severe anxiety would be (15-21). | Baseline, 6 months and 12 months | 
| Medical Outcomes Study Health Survey-Short Form | The quality of life was measured with the Medical Outcomes Study (MOS) Short Form Health Survey (SF-12) is a general measure of health status that assess the patient's perceived health status and whether health problems interfere with normal functioning. The SF-12 has demonstrated validity and test-retest reliability in the general population and in patients with chronic health conditions, and has been tested in five languages, including Spanish. It has been used extensively as a quality of life measure in collaborative care studies, including with low-income minority populations. It has also been used frequently in screening studies, for cancer and other conditions. The SF-12 has been validated as an indicator of effects of depression on quality of life in ethnically diverse patients. The continuous summary score was converted into 4 categories using quartiles as cutoff points. The four categories are Best Health, Good health, Fair Health and Worst Health. | Baseline, 6 months and 12 months | 
| Breast, Cervical and Colorectal Cancer Screening Attitudes | This measure was adapted from the National Cancer Institute's HINTS questions for colorectal cancer. The continuous summary score was converted into 4 categories using quartiles as cut points. The categories for screening attitudes were as follows: positive attitudes, moderate attitudes, fair attitudes and negative attitudes. | Baseline, 6 months and 12 months | 
| Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10) | The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have cervical, breast, and colon cancer screening.The satisfaction with decision scale of cancer screening and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point. | Baseline, 6 months and 12 months | 
| Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10) | The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have mental health care.The satisfaction with decision scale of mental health and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point. | 12 months | 
| Devaluation-Discrimination Scale | This measure was adapted from the Link's Devaluation-Discrimination Scale.The continuous summary score was converted into 4 categories using quartiles as cut points. The 4 categories were as follows: Low stigma, minimal stigma, moderate stigma and high stigma. | Baseline and 12 months | 
| Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey | The Ambulatory Care Experiences Survey produces 11 summary measures covering 2 broad dimensions of patients' experiences: quality of physician-patient interactions and organizational features of care. The continuous summary score was converted into 4 categories (High, Moderate, Fair and Low) using quartiles as cut-points. | Baseline, 6 months and 12 months | 
| Medication Adherence | In this questionnaire, respondents were asked if they had been prescribed medication for depression and about difficulties taking medication(s) regularly. Standard cut points was used for medical adherence. High adherence- around an 8. Medium adherence - 6-7.99. Low adherence would be anything less than 6. | Baseline, 6 months and 12 months | 
| Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization | This 5-item scale measures a sense of perceived self-efficacy associated with accessing and paying for the three different types of cancer screening and utilization of needed mental health services. The continuous study score was converted into 4 categories using quartiles as cut points. The 4 categories are high self-efficacy, moderate self- efficacy, minimal self-efficacy and low self-efficacy. | Baseline, 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening