Expired Study
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Shreveport, Louisiana 71130


Purpose:

In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual colorectal cancer (CRC) screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of this study is to compare the effectiveness of two distinct follow-up strategies to promote CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2. Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both follow-up strategies to investigate implementation and barriers 4. Determine if the effects of either strategy vary by patients' literacy skills. 5. Explore patient characteristics associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time between study arms.


Study summary:

The investigators objective is to compare the effectiveness of two distinct follow-up strategies to promote colorectal cancer screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project [R01CA115869] by adding a follow-up strategy to the health literacy intervention. In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual CRC screening using Fecal Immunochemical Test (FIT). Substantial evidence shows that routine screening can prevent colorectal cancer (CRC) or detect it at an early stage, reducing related mortality. While overall CRC screening rates in the US are increasing, rates remain persistently low among uninsured and low-income individuals, those with fewer years of education, and racial/ethnic minorities. Low health literacy has been linked to cancer screening noncompliance, higher rates of advanced stage of presentation of disease and health disparities. In response, the Department of Health and Human Services has called for health information and services that are accurate, accessible, and actionable as well as culturally appropriate. This study will implement a two-arm, randomized controlled trial with low income, underinsured patients in federally qualified health centers (FQHCs) to evaluate and compare the effectiveness of PC and ATR follow-up strategies to increase CRC screening. All patients recruited to the study will receive evidence-based, literacy appropriate screening materials developed using health literacy 'best practices' and a simplified FIT kit. Use of these materials has been shown to significantly increase CRC screening rates in the investigators ongoing study. Patients will be randomized to receive either: 1) the PC follow-up strategy, in which a PC personally reminds patients to complete and mail FIT kits, and perceived barriers to screening are discussed and addressed; or 2) the ATR follow-up strategy, in which an automated system electronically encourages patients to complete and mail FIT kits using plain language messages. The effectiveness of these two approaches will be compared at 12 and 24 months.


Criteria:

Inclusion Criteria: 1. a patient of the identified clinics, 2. age 50 to 75 (based on American Cancer Society (ACS) guidelines), and 3. can speak and understand English Exclusion Criteria: 1. previous history of cancer other than non-melanoma skin cancer, 2. up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years), 3. a first relative family history that requires a more complete history and possible colonoscopy because of their risk factor (these patients will be referred to their provider for follow-up), 4. an uncorrectable hearing or visual impairment, or 5. too ill to participate.


Study is Available At:


Original ID:

RSG-13-021-01 - CPPB


NCT ID:

NCT02360605


Secondary ID:

RSG-13-021-01 - CPPB


Study Acronym:


Brief Title:

Health Literacy Interventions to Overcome Disparities in CRC Screening


Official Title:

Health Literacy Interventions to Overcome Disparities in CRC Screening


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Louisiana State University Health Sciences Center Shreveport


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

620


Enrollment Type:

Actual


Study Dates

Start Date:February 2015
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:December 2018
Primary Completion Type:Anticipated
Verification Date:March 2018
Last Changed Date:March 5, 2018
First Received Date:February 5, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:effects of either strategy vary by patients' literacy
Time Frame:6 months after receipt of FIT kit
Safety Issues:False
Description:a term for literacy level (at or below 9th grade versus above 9th grade reading level) and a term for literacy by arm interaction will be added to the linear model to determine if either intervention varied by patient literacy
Outcome Type:Secondary Outcome
Measure:patients' understanding, beliefs and self-efficacy toward CRC screening over time.
Time Frame:24 months after enrollment
Safety Issues:False
Description:Explore patients' understanding, beliefs and self-efficacy toward CRC screening over time by analyzing pre and post-questionnaire responses on understanding, beliefs and self-efficacy.
Outcome Type:Primary Outcome
Measure:repeat CRC screening
Time Frame:between 12 and 18 months of previous screen
Safety Issues:False
Description:Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned).
Outcome Type:Primary Outcome
Measure:initial CRC screening
Time Frame:6 months after receipt of FIT kit
Safety Issues:False
Description:A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.

Study Interventions

Intervention Type:Behavioral
Name:automated telephone reminder
Description:The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions. Years 2 and 3: 12 months after patients returned their initial FIT (o
Arm Name:automated telephone reminder arm
Intervention Type:Behavioral
Name:prevention coordinator
Description:The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did
Arm Name:prevention coordinator arm
Intervention Type:Behavioral
Name:Health literacy appropriate education and demonstr
Description:The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day a
Arm Name:automated telephone reminder arm

Study Arms

Study Arm Type:Active Comparator
Arm Name:prevention coordinator arm
Description:Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
Study Arm Type:Active Comparator
Arm Name:automated telephone reminder arm
Description:Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Louisiana State University Health Sciences Center Shreveport
Agency Class:Other
Agency Type:Collaborator
Agency Name:Northwestern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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