跳至主要内容
临床试验/NCT02273206
NCT02273206已完成不适用

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

Clinical Directors Network8 个研究点 分布在 1 个国家目标入组 802 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
802
试验地点
8
主要终点
Assessment of Breast Cancer Screening Up to Date Status After Intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Prevention Care Management for Cancer Screening (Behavioral)

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.

干预措施: Prevention Care Management for Cancer Screening (Behavioral)

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.

干预措施: Prevention Care Management for Depression and Cancer Screening (Behavioral)

结局指标

主要结局

Assessment of Breast Cancer Screening Up to Date Status After Intervention

时间窗: Baseline - 12 months

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

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

时间窗: 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

时间窗: Baseline - 12 months

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

Assessment of Cervical Cancer Screening Up to Date Status After Intervention

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • Mental Health Care Utilization: Assessed by Patient Report(Baseline, 6 months and 12 months)
  • Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale(Baseline, 6 months and 12 months)
  • Physician Recommendation of Screening/Mental Health Care(Baseline, 6 months and 12 months)
  • Generalized Anxiety Disorder(Baseline, 6 months and 12 months)
  • Medical Outcomes Study Health Survey-Short Form(Baseline, 6 months and 12 months)
  • Breast, Cervical and Colorectal Cancer Screening Attitudes(Baseline, 6 months and 12 months)
  • Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10)(Baseline, 6 months and 12 months)
  • Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10)(12 months)
  • Devaluation-Discrimination Scale(Baseline and 12 months)
  • Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey(Baseline, 6 months and 12 months)
  • Medication Adherence(Baseline, 6 months and 12 months)
  • Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization(Baseline, 6 months and 12 months)

研究者

发起方
Clinical Directors Network
申办方类型
Network
责任方
Sponsor

研究点 (8)

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