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Colorectal Cancer Clinical Trial

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Testing Multimedia Approaches to Increase Participation in Colorectal Cancer Screening Among African Americans:  A Longitudinal, Multisite Randomized Clinical Trial

 

American Cancer Society

Study Investigators:  Barbara D. Powe PhD, RN (PI); Durado Brooks, MD, MPH

Elvan Daniels, MD, MPH; Margaret Offermann, MD, PhD; Ken Portier, PhD, Linda Blount, MPH

 

What are the Benefits to Participation?

Patient Benefits

ü  Identify evidence-based approaches to increase CRC knowledge among African Americans.

ü  Enhanced ability to make informed decisions about CRC screening.

ü  Engage African Americans in research vital to the elimination of health disparities

 

Provider Benefits

ü  Access to tools and resources designed to increase colorectal cancer screening rates in your practice

ü  Engage in research (publications, submit questions for surveys)

ü  Financial stipend for completing study ($1000 per year for each full year practice is engaged in the study – paid at the end of the year).  There is a bonus payment of $1000 for practices who stay in the study for the full 4-year period.

ü  Expand partnership with American Cancer Society

                         

What is the Primary Objective of the Study?

 

This study aims to compare the effectiveness of culturally relevant patient focused, system (healthcare, employer) focused, and American Cancer Society (ACS) focused interventions delivered over time on participation in colorectal cancer screening (FIT, colonoscopy) and repeat screening (baseline, 12-months, 24-months, 36-months, 48-months) among African Americans aged 49 and older who attend federally qualified health centers and primary care practices in Georgia and Florida.  This study also aims to identify the most effective interventions needed to decrease known barriers to screening.  With regard to policy and advocacy barriers, this study aims to document real and perceived access to colonoscopy for participants who choose this option and evaluate the relationship between participation in CRC screening and adherence to other age-appropriate cancer screenings   Lastly, this study aims to evaluate the effectiveness of ACS materials to increase cancer knowledge, decrease psychosocial barriers, and increase participation in CRC screening.

 

What is the Investigators Role and Responsibilities of the Practices?

ü  Allow ACS and study personnel to recruit participants from practice at baseline and deliver the first intervention (5-7 day period).

ü  Provide short-term office space at practice for study personnel to recruit participants, and for participants to view a DVD while at the practice at baseline (will occur during the 5-7 day period noted above).

ü  Provide space for an intervention kiosk and other materials during the baseline data collection period (approximately 5 – 7 days),

ü  Allow staff to assist in recruitment of participants by recommending patients and encouraging patients to participate.

ü  Identify key staff liaison for study (nurse or social worker) who will receive the results of CRC screening, assist in scheduling colonoscopy and follow-up testing, assist in contacting participants with positive tests or who need follow-up, document screening findings in the medical record, assist with possible medical record reviews (screening), and assist in identifying funding for colonoscopy and follow-up treatment usually used for participants at the practice, as indicated.  A stipend will be provided to cover the percentage of time allotted to this person.

ü  Allow the staff liaison to participate in quarterly meetings of the study team. 

ü  If practice is placed in the system focused study group, provide copy of practice letterhead and electronic access to practice logo to place on study materials that will be mailed to participants.

ü  If practice is placed in the system focused study group, allow providers to sign reminder letters to patients (need electronic signature) and make a 30-second recording encouraging patients to participate in CRC screening (script will be provided and recording scheduled at provider’s convenience). 

ü  If practice is placed in the system focused study group, allow a nurse navigator to work with the participant and the staff liaison to facilitate screening. 

ü  Additional requirements as needed to support the study.

 

 

Note:  While this is a 48-month study, only the initial data collection will occur at the practice.  All other data collection will occur via mail or phone excluding colonoscopy and follow-up care.  FIT kits will be given to participants at baseline and mailed to annually.

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