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出境医 / 临床实验 / Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk (CHURCH)

Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk (CHURCH)

Study Description
Brief Summary:

The overarching goal of this proposal is to create a scalable community-academic partnership model for colorectal cancer (CRC) and cardiovascular disease (CVD) prevention for African American (AA) communities. Our dual intervention approach allows us to target two major killers of AAs, and aggressively pursue the mandate of this Program Announcement. We aim to (1) increase guideline concordant10 CRC screening uptake using a community health worker (CHW)-Led SBIRT intervention (Primary Outcome); and (2) reduce dietary and CVD risk factors linked to CRC (Secondary Outcomes). The latter will be addressed by culturally adapting an existing, evidence-based, web-based lifestyle program called Alive!, which has been shown in several RCTs to improve CVD outcomes. Using a Hybrid Type 1 Implementation-Effectiveness design, we will randomize 440 subjects from 22 AA churches into a cluster RCT to accomplish the following:

Specific Aim 1: To compare the effect of SBIRT (Intervention) to Referral As Usual (RAU) (Usual Care) on guideline-concordant CRC screening uptake. Hypothesis: Intervention will lead to increased CRC screening uptake (colonoscopy, fecal DNA) (Primary Outcome) compared to RAU at 6-months.

Aim 2: To evaluate the effect of a Culturally-adapted Alive! Program (CAP) incorporated into the intervention arm on dietary inflammatory score (DIS). Hypothesis: participants in the CAP arm will have lower DIS scores compared to RAU at 6-months.

Aim 3: To evaluate the effect of CAP on changes in Life Simple-7 (LS7) scores. Hypothesis: participants in the CAP arm will have improvement in LS7 scores compared to RAU at 6-months and 1 year.

Aim 4: To examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CAP activities. Guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR) we will conduct a mixed methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. This information will inform future dissemination and scale-up of this intervention.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: SBIRT Behavioral: Referral as Usual (RAU) Not Applicable

Detailed Description:
Colorectal cancer (CRC) is the second most lethal cancer in the U.S with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, which includes premature mortality, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. Lower screening rates are linked to the downstream effects of structural inequities such as access to care, knowledge of screening options and benefits, health system mistrust, fear and anxiety. Although reducing the burden of CRC is best accomplished by screening, compelling evidence links inflammatory diets and cardiovascular disease (CVD) risk factors to increased CRC risk. In response to RFA-MD-21-007 to address two or more chronic diseases that commonly co-occur, share social contexts or risk factors, this proposal aims to develop a community-based prevention model to reduce CRC and CVD risk among AAs.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
Estimated Study Start Date : June 15, 2022
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : September 15, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Screening, Brief Intervention, and Referral to Treatment (SBIRT)

1a) SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.

1b) We will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control.

 Behavioral: SBIRT

1a) SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.

1b) We will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control

Other Name: Culturally-adapted ALIVE! Program (CAP)
Active Comparator: Referral as Usual (RAU)
Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.
 Behavioral: Referral as Usual (RAU)
Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.
Outcome Measures
Primary Outcome Measures :
  1. CRC Screening Uptake [ Time Frame: Measured at 6 months post-screening ]

    CRC screening uptake (colonoscopy, stool-based test) (Primary Outcome).

    This cluster RCT will evaluate the impact of a CHW enhanced CRC screening intervention on screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome). The definition of screening uptake is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records.

    Screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome) is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records.



Secondary Outcome Measures :
  1. Change in Dietary Inflammatory Score (Dietary Screening Measure) [ Time Frame: Measured at baseline and 6 months post-screening ]
    Assessment of participant eating habits via the culturally-adapted ALIVE! program will be captured by the Block Food Frequency Questionnaire (FFQ) that generates the dietary inflammatory score (DIS) which can be used to examine associations between inflammatory diets, cardiovascular diseases and colorectal cancer.

  2. Change in Life's Simple 7 Score (CVD Risk Screening Measure) [ Time Frame: Measured at baseline, 6 months and 1 year post-screening ]
    Evaluation of CVD risk factors using the Life Simple-7 (LS7) measure. LS7 scores range from 0 to 14 and are calculated from the composite of the factor scores. CVD health is then classified as inadequate (0-4), average (5-9), or optimum (10-14). Achieving a greater number of ideal LS7 metrics is associated with lower risk of dying after stroke and all cause cardiovascular mortality in a dose dependent manner.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. English-speaking
  2. Self-identifying as Black
  3. Aged 45 years and older
  4. Not up-to-date with CRC
  5. Working telephone
  6. Can provide informed consent

Exclusion Criteria:

  • None
Contacts and Locations

Locations
Layout table for location information
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Tracking Information
First Submitted Date  ICMJE November 5, 2021
First Posted Date  ICMJE December 30, 2021
Last Update Posted Date December 30, 2021
Estimated Study Start Date  ICMJE June 15, 2022
Estimated Primary Completion Date September 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2021) 		CRC Screening Uptake [ Time Frame: Measured at 6 months post-screening ]
CRC screening uptake (colonoscopy, stool-based test) (Primary Outcome). This cluster RCT will evaluate the impact of a CHW enhanced CRC screening intervention on screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome). The definition of screening uptake is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records. Screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome) is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2021)
  • Change in Dietary Inflammatory Score (Dietary Screening Measure) [ Time Frame: Measured at baseline and 6 months post-screening ]
    Assessment of participant eating habits via the culturally-adapted ALIVE! program will be captured by the Block Food Frequency Questionnaire (FFQ) that generates the dietary inflammatory score (DIS) which can be used to examine associations between inflammatory diets, cardiovascular diseases and colorectal cancer.
  • Change in Life's Simple 7 Score (CVD Risk Screening Measure) [ Time Frame: Measured at baseline, 6 months and 1 year post-screening ]
    Evaluation of CVD risk factors using the Life Simple-7 (LS7) measure. LS7 scores range from 0 to 14 and are calculated from the composite of the factor scores. CVD health is then classified as inadequate (0-4), average (5-9), or optimum (10-14). Achieving a greater number of ideal LS7 metrics is associated with lower risk of dying after stroke and all cause cardiovascular mortality in a dose dependent manner.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
Official Title  ICMJE Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
Brief Summary

The overarching goal of this proposal is to create a scalable community-academic partnership model for colorectal cancer (CRC) and cardiovascular disease (CVD) prevention for African American (AA) communities. Our dual intervention approach allows us to target two major killers of AAs, and aggressively pursue the mandate of this Program Announcement. We aim to (1) increase guideline concordant10 CRC screening uptake using a community health worker (CHW)-Led SBIRT intervention (Primary Outcome); and (2) reduce dietary and CVD risk factors linked to CRC (Secondary Outcomes). The latter will be addressed by culturally adapting an existing, evidence-based, web-based lifestyle program called Alive!, which has been shown in several RCTs to improve CVD outcomes. Using a Hybrid Type 1 Implementation-Effectiveness design, we will randomize 440 subjects from 22 AA churches into a cluster RCT to accomplish the following:

Specific Aim 1: To compare the effect of SBIRT (Intervention) to Referral As Usual (RAU) (Usual Care) on guideline-concordant CRC screening uptake. Hypothesis: Intervention will lead to increased CRC screening uptake (colonoscopy, fecal DNA) (Primary Outcome) compared to RAU at 6-months.

Aim 2: To evaluate the effect of a Culturally-adapted Alive! Program (CAP) incorporated into the intervention arm on dietary inflammatory score (DIS). Hypothesis: participants in the CAP arm will have lower DIS scores compared to RAU at 6-months.

Aim 3: To evaluate the effect of CAP on changes in Life Simple-7 (LS7) scores. Hypothesis: participants in the CAP arm will have improvement in LS7 scores compared to RAU at 6-months and 1 year.

Aim 4: To examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CAP activities. Guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR) we will conduct a mixed methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. This information will inform future dissemination and scale-up of this intervention.
Detailed Description Colorectal cancer (CRC) is the second most lethal cancer in the U.S with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, which includes premature mortality, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. Lower screening rates are linked to the downstream effects of structural inequities such as access to care, knowledge of screening options and benefits, health system mistrust, fear and anxiety. Although reducing the burden of CRC is best accomplished by screening, compelling evidence links inflammatory diets and cardiovascular disease (CVD) risk factors to increased CRC risk. In response to RFA-MD-21-007 to address two or more chronic diseases that commonly co-occur, share social contexts or risk factors, this proposal aims to develop a community-based prevention model to reduce CRC and CVD risk among AAs.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Behavioral: SBIRT

    1a) SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.

    1b) We will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control

    Other Name: Culturally-adapted ALIVE! Program (CAP)
  • Behavioral: Referral as Usual (RAU)
    Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.
Study Arms  ICMJE
  • Experimental: Screening, Brief Intervention, and Referral to Treatment (SBIRT)

    1a) SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.

    1b) We will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control.

    Intervention: Behavioral: SBIRT
  • Active Comparator: Referral as Usual (RAU)
    Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.
    Intervention: Behavioral: Referral as Usual (RAU)
Publications *
  • Jackson CS, Oman M, Patel AM, Vega KJ. Health disparities in colorectal cancer among racial and ethnic minorities in the United States. J Gastrointest Oncol. 2016 Apr;7(Suppl 1):S32-43. doi: 10.3978/j.issn.2078-6891.2015.039. Review.
  • De Jesus M, Puleo E, Shelton RC, McNeill LH, Emmons KM. Factors associated with colorectal cancer screening among a low-income, multiethnic, highly insured population: does provider's understanding of the patient's social context matter? J Urban Health. 2010 Mar;87(2):236-243. doi: 10.1007/s11524-009-9420-1. Epub 2009 Dec 31.
  • Sly JR, Edwards T, Shelton RC, Jandorf L. Identifying barriers to colonoscopy screening for nonadherent African American participants in a patient navigation intervention. Health Educ Behav. 2013 Aug;40(4):449-57. doi: 10.1177/1090198112459514. Epub 2012 Oct 19.
  • Lumpkins CY, Coffey CR, Daley CM, Greiner KA. Employing the church as a marketer of cancer prevention: a look at a health promotion project aimed to reduce colorectal cancer among African Americans in the Midwest. Fam Community Health. 2013 Jul-Sep;36(3):215-23. doi: 10.1097/FCH.0b013e31829159ed.
  • Maxwell AE, Lucas-Wright A, Santifer RE, Vargas C, Gatson J, Chang LC. Promoting Cancer Screening in Partnership With Health Ministries in 9 African American Churches in South Los Angeles: An Implementation Pilot Study. Prev Chronic Dis. 2019 Sep 19;16:E128. doi: 10.5888/pcd16.190135.
  • Shelton RC, Thompson HS, Jandorf L, Varela A, Oliveri B, Villagra C, Valdimarsdottir HB, Redd WH. Training experiences of lay and professional patient navigators for colorectal cancer screening. J Cancer Educ. 2011 Jun;26(2):277-84. doi: 10.1007/s13187-010-0185-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2021) 		880
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2025
Estimated Primary Completion Date September 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. English-speaking
  2. Self-identifying as Black
  3. Aged 45 years and older
  4. Not up-to-date with CRC
  5. Working telephone
  6. Can provide informed consent

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05174286
Other Study ID Numbers  ICMJE AAAT9307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared through submission of study findings to peer-reviewed journals. De-identified data will also be shared at community forums and academic conferences.
Supporting Materials: Study Protocol
Time Frame: Data will be available six months after publication in a peer-reviewed journal article.
Access Criteria: The study Investigators, Dr. Olajide Williams, will create criteria and review requests for data sharing access. Data will be available to analyze types of clinical and demographic factors impact study outcomes.
Responsible Party Olajide Williams, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Columbia University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP