Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Depression

Breast Neoplasms

Depressive Disorder

Uterine Cervical Neoplasms

Colorectal Neoplasms

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

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.

Prevention Care Management for Depression and Cancer Screening

Prevention Care Management for Cancer Screening

Elisa Weiss, PhD

Jonathan N Tobin, PhD

Andrea Cassells, MPH

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.

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

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

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)

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

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

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

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.

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.

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).

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.

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.

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

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).

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.

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.

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.

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.

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.

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.

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.

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.

Clinical Directors Network

Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services

Collaborative Care Intervention (CCI)

The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening

Prevention Care Management (PCM) Intervention

Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services.

The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Some participants did not provide a response for this question.

Race (NIH/OMB)

United States

Region of Enrollment

English

Spanish

Primary Language

Born in U.S.

Born outside of U.S.

Country of Birth

Married/cohabitating

Single/divorced/widowed/separated

Other

Marital Status

Less than 8 years

8-11 years

Completed High School

Post High School and higher

Education

Employed

Unemployed

Homemaker

Employment

$0 to $9,999

$10,000 to $14,999

$15,000 or more

Household income

Medicaid + Medicare

Medicaid

Medicare

Employer

No insurance

Insurance

≥ 3

Years receiving care at the community health center before consent

Mild Depression (5-9)

Moderate Depression (10-14)

Moderately Severe Depression (15-19)

Severe Depression (20-27)

Patient Health Questionnaire-9 (PHQ9) Score Group

Up to date for Colorectal Cancer Screening

Up to date for Breast Cancer Screening

Up to date for Cervical Cancer Screening

Cancer Screening

Cancer history

Hysterectomy

Current

Former

Never

Electronic health record data for this measure is not available for all participants.

Smoking Status

Comorbid Condition- Asthma

Comorbid Condition- Hypertension

Comorbid Condition- Hyperlipidemia

Comorbid Condition- Diabetes

Colorectal Cancer Screening Intervention Arm Difference

Breast Cancer Screening Intervention Arm Difference

Cervical Cancer Screening Intervention Arm Difference

Colorectal Cancer Screening - Baseline

Colorectal Cancer Screening - Follow Up

Breast Cancer Screening - Baseline

Breast Cancer Screening - Follow Up

Cervical Cancer Screening - Baseline

Cervical Cancer Screening - Follow Up

Prevention Care Management (PCM)

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

Up to Date at Baseline

Up to Date at Follow Up

Assessment of Colorectal Cancer Screening Up to Date Status After Intervention

Assessment of Breast Cancer Screening Up to Date Status After Intervention

Assessment of Cervical Cancer Screening Up to Date Status After Intervention

PHQ9 Intervention Arm Difference between baseline and 12-month follow up

Mean PHQ9 Score at Baseline

Mean PHQ9 Score at Follow Up

Mean Change in PHQ9 Score

These data are collected at baseline and 12 months. Not all participants completed all instruments at both time points.

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

The Hopkins Symptom Checklist (SCL-20) at baseline.

The Hopkins Symptom Checklist (SCL-20) at 6 Months

Baseline

6 month

This data is collected at baseline and 6 months. Not all participants completed all instruments at all time points.

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

The Hopkins Symptom Checklist (SCL-20) at Baseline.

The Hopkins Symptom Checklist (SCL-20) at 12 months.

12 Months

This data is collected at baseline and 12 months. Not all participants completed all instruments at all time points.

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

Colorectal Cancer Screening Intervention Arm Difference at 12 Months

Cervical Cancer Screening Intervention Arm Difference at 12 Months

Breast Cancer Screening Intervention Arm Difference at 12 Months

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

Mental Health Care Utilization - Mental Health Visits at baseline.

Mental Health Care Utilization - Mental Health Visits at 6 months.

Mental Health Care Utilization - Mental Health Visits at 12 months.

Mental Health Care Utilization - Mental Health Prescriptions at baseline.

Mental Health Care Utilization - Mental Health Prescriptions at 6 months.

Mental Health Care Utilization - Mental Health Prescriptions at 12 months.

Mental Health Visits - Baseline

Mental Health Visits - 6 Months

Mental Health Visits - 12 Months

Mental Health Prescriptions - Baseline

Mental Health Prescriptions - 6 Months

Mental Health Prescriptions - 12 Months

This data is collected at baseline, 6 months and 12 months for 3 different instruments. Not all participants completed all instruments at all time points.

Mental Health Care Utilization: Assessed by Patient Report

Satisfaction with decision to participate in colorectal cancer screening at baseline.

Satisfaction with decision to participate in colorectal cancer screening at 6 months.

Satisfaction with decision to participate in colorectal cancer screening at 12 months.

Satisfaction with decision to participate in breast cancer screening at baseline.

Satisfaction with decision to participate in breast cancer screening at 6 months.

Satisfaction with decision to participate in breast cancer screening at 12 months.

Satisfaction with decision to participate in cervical cancer screening at baseline.

Satisfaction with decision to participate in cervical cancer screening at 6 months.

Satisfaction with decision to participate in cervical cancer screening at 12 months.

Satisfaction with decision to participate in Mental Health Care at 12 months.

Colorectal Cancer Screening - 6 months

Colorectal Cancer Screening - 12 months

Breast Cancer Screening - 6 months

Breast Cancer Screening - 12 months

Cervical Cancer Screening - 6 months

Cervical Cancer Screening - 12 Months

Mental Health Care - 12 Months

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

Physician Recommendation of Colorectal Cancer Screening at baseline.

Physician Recommendation of Colorectal Cancer Screening at 6 months.

Physician Recommendation of Colorectal Cancer Screening at 12 months.

Physician Recommendation of Breast Cancer Screening at baseline.

Data are collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women	NCT02273206	Depression Breast Cancer S... Cervical Cancer... Colorectal Canc...	Prevention Care... Prevention Care...	50 Years - 64 Years	Clinical Directors Network
Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women	NCT02273206	Depression Breast Cancer S... Cervical Cancer... Colorectal Canc...	Prevention Care... Prevention Care...	50 Years - 64 Years	Clinical Directors Network

Spots Global Cancer Trial Database for prevention care management for cancer screening