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.
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
- Conditions the study is for
- Depression, Breast Cancer Screening, Cervical Cancer Screening
- What is being tested?
- Prevention Care Management for Depression and Cancer Screening and Prevention Care Management for Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening
- 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 group | Role | What they receive |
|---|---|---|
| Prevention Care Management for Cancer Screening | 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. Receives: Behavioral: Prevention Care Management for Cancer Screening |
| Prevention Care Management for Depression and Cancer Screening | 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. 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.
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted23 Oct 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinical Directors Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elisa Weiss, PhD, Principal investigator, The Leukemia and Lymphoma SocietyJonathan N Tobin, PhD, Principal investigator, Clinical Directors NeworkAndrea Cassells, MPH, Study director, Clinical Directors Network
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project
- ClinicalTrials.gov ID
- NCT02273206
- Acronym / sponsor ID
- PCM3 / IH-12-11-4522
- Conditions
- Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening
- Keywords
- Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Clinical Directors NetworkResearch network
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Care Management for Cancer Screening | Active comparator | Behavioral: Prevention Care Management for Cancer ScreeningThe Care Manager will focus 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 | Experimental | Behavioral: Prevention Care Management for Depression and Cancer Screening, Behavioral: Prevention Care Management for Cancer ScreeningThe 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. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Resident of the Bronx
- Overdue for breast, cervical or colorectal cancer screening
- Screen positive for depression
- No cancer diagnosis within the past six months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention Care Management for Depression and Cancer ScreeningAlso: Collaborative Care Intervention (CCI) | Behavioural | Prevention Care Management for Depression and Cancer Screening |
| Prevention Care Management for Cancer ScreeningAlso: Prevention Care Manager (PCM) | Behavioural | Prevention Care Management for Cancer Screening, Prevention Care Management for Depression and Cancer Screening |
Primary outcome
Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status
Time frame: Baseline - 12 months
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)
Assessment of Colorectal Cancer Screening Up to Date Status After Intervention
Time frame: Baseline - 12 months
Multivariate logistic regression model was used to assess which factors contributed to colorectal cancer screening up to date status.
Assessment of Breast Cancer Screening Up to Date Status After Intervention
Time frame: Baseline - 12 months
Multivariate logistic regression model was used to assess which factors contributed to breast cancer screening up to date status
Assessment of Cervical Cancer Screening Up to Date Status After Intervention
Time frame: Baseline - 12 months
Multivariate logistic regression model was used to assess which factors contributed to cervical cancer screening up to date status
Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm
Time frame: Baseline - 12 months
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.
Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months
Time frame: Baseline - 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.
Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months
Time frame: Baseline - 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.
Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening
Time frame: Baseline - 12 months
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).
12 secondary outcomes
Mental Health Care Utilization: Assessed by Patient Report
Time frame: Baseline, 6 months and 12 months
Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale
Time frame: Baseline, 6 months and 12 months
Physician Recommendation of Screening/Mental Health Care
Time frame: Baseline, 6 months and 12 months
Generalized Anxiety Disorder
Time frame: Baseline, 6 months and 12 months
Medical Outcomes Study Health Survey-Short Form
Time frame: Baseline, 6 months and 12 months
Breast, Cervical and Colorectal Cancer Screening Attitudes
Time frame: Baseline, 6 months and 12 months
Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10)
Time frame: Baseline, 6 months and 12 months
Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10)
Time frame: 12 months
Devaluation-Discrimination Scale
Time frame: Baseline and 12 months
Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey
Time frame: Baseline, 6 months and 12 months
Medication Adherence
Time frame: Baseline, 6 months and 12 months
Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization
Time frame: Baseline, 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34803050Tobin 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.
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Weiss, PhD principal investigator
The Leukemia and Lymphoma Society
Jonathan N Tobin, PhD principal investigator
Clinical Directors Nework
Andrea Cassells, MPH study director
Clinical Directors Network
8 sites in 1 country: see every site and its status.
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.