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DepressionPCM3NCT02273206

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

A study testing Prevention Care Management for Depression and Cancer Screening and Prevention Care Management for Cancer Screening in people with Depression and Breast Cancer Screening, run by Clinical Directors Network at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 64 years, women only
What is being tested?
Prevention Care Management for Depression and Cancer Screening and Prevention Care Management for Cancer Screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
802 participants
Where
8 sitesUnited States
Study dates
Jan 2014to 31 Dec 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • Lincoln Ambulatory Care Practice

    The Bronx, New York, 10451

  • Morrissania Diagnostic and Treatment Center

    The Bronx, New York, 10452

  • Morris Heights Health Center

    The Bronx, New York, 10453

  • Segundo Ruiz Belvis Diagnostic and Treatment Center

    The Bronx, New York, 10454

  • BronwWorks

    The Bronx, New York, 10456

  • Urban Health Plan

    The Bronx, New York, 10459

  • Montefiore Family Care Center

    The Bronx, New York, 10467

  • Good Shepherd Service

    The Bronx, New York, 10468

Other trials in United States

About this study

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

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.

Being tested
Prevention Care Management for Depression and Cancer Screening, Prevention Care Management for Cancer Screening
Keywords
Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prevention Care Management for Depression and Cancer ScreeningBehavioural

    Also called Collaborative Care Intervention (CCI)

  • Prevention Care Management for Cancer ScreeningBehavioural

    Also called Prevention Care Manager (PCM)

Study groups in NCT02273206
Study groupRoleWhat they receive
Prevention Care Management for Cancer ScreeningActive comparatorThe Care Manager will focus on cancer screening, providing education, patient navigation, and motivational support to overcome screening barriers and form favorable attitudes towards screening.
Receives: Behavioral: Prevention Care Management for Cancer Screening
Prevention Care Management for Depression and Cancer ScreeningExperimentalThe 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.
Receives: Behavioral: Prevention Care Management for Depression and Cancer Screening; Behavioral: Prevention Care Management for Cancer Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline - 12 months

  2. 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.

    Measured: Baseline - 12 months

  3. 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

    Measured: Baseline - 12 months

  4. 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

    Measured: Baseline - 12 months

  5. 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.

    Measured: Baseline - 12 months

  6. 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.

    Measured: Baseline - 6 months

  7. 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.

    Measured: Baseline - 12 months

  8. 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).

    Measured: Baseline - 12 months

Secondary outcomes (12)
  1. 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.

    Measured: Baseline, 6 months and 12 months

  2. 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.

    Measured: Baseline, 6 months and 12 months

  3. 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

    Measured: Baseline, 6 months and 12 months

  4. 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).

    Measured: Baseline, 6 months and 12 months

  5. 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.

    Measured: Baseline, 6 months and 12 months

  6. 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.

    Measured: Baseline, 6 months and 12 months

  7. 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.

    Measured: Baseline, 6 months and 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: Baseline and 12 months

  10. 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.

    Measured: Baseline, 6 months and 12 months

  11. 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.

    Measured: Baseline, 6 months and 12 months

  12. 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.

    Measured: Baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study startJan 2014
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273206
Sponsor's protocol ID
IH-12-11-4522
Acronym
PCM3
Status last verified
Feb 2020
First submitted
17 Oct 2014
Last updated
12 Mar 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 34803050

Questions about this trial

What is this clinical trial studying?

A study testing Prevention Care Management for Depression and Cancer Screening and Prevention Care Management for Cancer Screening in people with Depression and Breast Cancer Screening, run by Clinical Directors Network at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status (time frame: Baseline - 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273206, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.

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