Colorectal CancerNCT02360605
Health Literacy Interventions to Overcome Disparities in CRC Screening
A study testing automated telephone reminder, prevention coordinator and Health literacy appropriate education and demonstration in people with Colorectal Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- automated telephone reminder, prevention coordinator and Health literacy appropriate education and demonstration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 6 Nov 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a patient of the identified clinics,
- age 50 to 75 (based on American Cancer Society (ACS) guidelines), and
- can speak and understand English
Who cannot join
- previous history of cancer other than non-melanoma skin cancer,
- up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),
- 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),
- an uncorrectable hearing or visual impairment, or
- too ill to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
Shreveport, Louisiana, 71130
About this study
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- automated telephone reminder, prevention coordinator, Health literacy appropriate education and demonstration
- Keywords
- colorectal cancer screening, low literacy, community clinics, Fecal Immunochemical Test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated telephone reminderBehavioural
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 (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.
prevention coordinatorBehavioural
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 not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.
Health literacy appropriate education and demonstrationBehavioural
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 and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| automated telephone reminder arm | Active comparator | 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. Receives: Behavioral: automated telephone reminder; Behavioral: Health literacy appropriate education and demonstration |
| prevention coordinator arm | Active comparator | 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. Receives: Behavioral: prevention coordinator; Behavioral: Health literacy appropriate education and demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial CRC Screening
A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.
Measured: 6 months after receipt of FIT kit
Repeat CRC Screening
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). Year 2 primary outcome is number of participants who return a FIT for 2 years.
Measured: between 12 and 18 months of previous screen, 2 years overall
Repeat Screening
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). Year 3 primary outcome is number of participants who return a FIT all 3 years.
Measured: between 12 and 18 months of previous screen, 2 years overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
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 (26)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Loyola University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360605
- Sponsor's protocol ID
- RSG-13-021-01 - CPPB
- Other IDs
- RSG-13-021-01 - CPPB
- Status last verified
- Jun 2021
- First submitted
- 5 Feb 2015
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology. 2008 May;134(5):1570-95. doi: 10.1053/j.gastro.2008.02.002. Epub 2008 Feb 8.
PubMed 18384785Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.
PubMed 19998273Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Keating NL, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. National Institutes of Health state-of-the-science conference statement: Enhancing use and quality of colorectal cancer screening. Ann Intern Med. 2010 May 18;152(10):663-7. doi: 10.7326/0003-4819-152-10-201005180-00237. Epub 2010 Apr 13. No abstract available.
PubMed 20388702Taplin SH, Haggstrom D, Jacobs T, Determan A, Granger J, Montalvo W, Snyder WM, Lockhart S, Calvo A. Implementing colorectal cancer screening in community health centers: addressing cancer health disparities through a regional cancer collaborative. Med Care. 2008 Sep;46(9 Suppl 1):S74-83. doi: 10.1097/MLR.0b013e31817fdf68.
PubMed 18725837Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening among adults aged 50-75 years - United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Jul 9;59(26):808-12.
PubMed 20613704Davis TC, Dolan NC, Ferreira MR, Tomori C, Green KW, Sipler AM, Bennett CL. The role of inadequate health literacy skills in colorectal cancer screening. Cancer Invest. 2001;19(2):193-200. doi: 10.1081/cnv-100000154.
PubMed 11296623Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health literacy and cancer communication. CA Cancer J Clin. 2002 May-Jun;52(3):134-49. doi: 10.3322/canjclin.52.3.134.
PubMed 12018928Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.
PubMed 15226329Burt RW. Strategies for colon cancer screening with considerations of cost and access to care. J Natl Compr Canc Netw. 2010 Jan;8(1):2-5. doi: 10.6004/jnccn.2010.0002. No abstract available.
PubMed 20064288O'Malley AS, Beaton E, Yabroff KR, Abramson R, Mandelblatt J. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Prev Med. 2004 Jul;39(1):56-63. doi: 10.1016/j.ypmed.2004.02.022.
PubMed 15207986Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
PubMed 18304342Greiner KA, Born W, Nollen N, Ahluwalia JS. Knowledge and perceptions of colorectal cancer screening among urban African Americans. J Gen Intern Med. 2005 Nov;20(11):977-83. doi: 10.1111/j.1525-1497.2005.00165.x.
PubMed 16307620Davis TC, Arnold CL, Rademaker AW, Platt DJ, Esparza J, Liu D, Wolf MS. FOBT completion in FQHCs: impact of physician recommendation, FOBT information, or receipt of the FOBT kit. J Rural Health. 2012 Summer;28(3):306-11. doi: 10.1111/j.1748-0361.2011.00402.x. Epub 2012 Jan 24.
PubMed 22757955Arnold CL, Rademaker A, Bailey SC, Esparza JM, Reynolds C, Liu D, Platt D, Davis TC. Literacy barriers to colorectal cancer screening in community clinics. J Health Commun. 2012;17 Suppl 3(0 3):252-64. doi: 10.1080/10810730.2012.713441.
PubMed 23030574Khankari K, Eder M, Osborn CY, Makoul G, Clayman M, Skripkauskas S, Diamond-Shapiro L, Makundan D, Wolf MS. Improving colorectal cancer screening among the medically underserved: a pilot study within a federally qualified health center. J Gen Intern Med. 2007 Oct;22(10):1410-4. doi: 10.1007/s11606-007-0295-0. Epub 2007 Jul 26.
PubMed 17653808
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy Interventions to Overcome Disparities in CRC Screening
- ClinicalTrials.gov ID
- NCT02360605
- Acronym / sponsor ID
- RSG-13-021-01 - CPPB
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, low literacy, community clinics, Fecal Immunochemical Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Northwestern University, Loyola University
- Study start
- Feb 2015
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| automated telephone reminder arm | Active comparator | Behavioral: automated telephone reminder, Behavioral: Health literacy appropriate education and demonstrationPatients 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. |
| prevention coordinator arm | Active comparator | Behavioral: prevention coordinator, Behavioral: Health literacy appropriate education and demonstrationPatients 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a patient of the identified clinics,
- age 50 to 75 (based on American Cancer Society (ACS) guidelines), and
- can speak and understand English
Key exclusion criteria (5 listed)
- previous history of cancer other than non-melanoma skin cancer,
- up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),
- 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),
- an uncorrectable hearing or visual impairment, or
- too ill to participate.
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 |
|---|---|---|
| automated telephone reminderThe 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 (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3. | Behavioural | automated telephone reminder arm |
| prevention coordinatorThe 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 not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3. | Behavioural | prevention coordinator arm |
| Health literacy appropriate education and demonstrationThe 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 and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months. | Behavioural | automated telephone reminder arm, prevention coordinator arm |
Primary outcome
Initial CRC Screening
Time frame: 6 months after receipt of FIT kit
A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.
Repeat CRC Screening
Time frame: between 12 and 18 months of previous screen, 2 years overall
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). Year 2 primary outcome is number of participants who return a FIT for 2 years.
Repeat Screening
Time frame: between 12 and 18 months of previous screen, 2 years overall
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). Year 3 primary outcome is number of participants who return a FIT all 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18384785Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology. 2008 May;134(5):1570-95. doi: 10.1053/j.gastro.2008.02.002. Epub 2008 Feb 8.
- Background: PubMed 19998273Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.
- Background: PubMed 20388702Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Keating NL, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. National Institutes of Health state-of-the-science conference statement: Enhancing use and quality of colorectal cancer screening. Ann Intern Med. 2010 May 18;152(10):663-7. doi: 10.7326/0003-4819-152-10-201005180-00237. Epub 2010 Apr 13. No abstract available.
- Background: PubMed 18725837Taplin SH, Haggstrom D, Jacobs T, Determan A, Granger J, Montalvo W, Snyder WM, Lockhart S, Calvo A. Implementing colorectal cancer screening in community health centers: addressing cancer health disparities through a regional cancer collaborative. Med Care. 2008 Sep;46(9 Suppl 1):S74-83. doi: 10.1097/MLR.0b013e31817fdf68.
- Background: PubMed 20613704Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening among adults aged 50-75 years - United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Jul 9;59(26):808-12.
- Background: PubMed 11296623Davis TC, Dolan NC, Ferreira MR, Tomori C, Green KW, Sipler AM, Bennett CL. The role of inadequate health literacy skills in colorectal cancer screening. Cancer Invest. 2001;19(2):193-200. doi: 10.1081/cnv-100000154.
- Background: PubMed 12018928Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health literacy and cancer communication. CA Cancer J Clin. 2002 May-Jun;52(3):134-49. doi: 10.3322/canjclin.52.3.134.
- Background: PubMed 15226329Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.
- Background: PubMed 20064288Burt RW. Strategies for colon cancer screening with considerations of cost and access to care. J Natl Compr Canc Netw. 2010 Jan;8(1):2-5. doi: 10.6004/jnccn.2010.0002. No abstract available.
- Background: PubMed 15207986O'Malley AS, Beaton E, Yabroff KR, Abramson R, Mandelblatt J. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Prev Med. 2004 Jul;39(1):56-63. doi: 10.1016/j.ypmed.2004.02.022.
- Background: PubMed 18304342Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
- Background: PubMed 16307620Greiner KA, Born W, Nollen N, Ahluwalia JS. Knowledge and perceptions of colorectal cancer screening among urban African Americans. J Gen Intern Med. 2005 Nov;20(11):977-83. doi: 10.1111/j.1525-1497.2005.00165.x.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated telephone reminder, prevention coordinator and Health literacy appropriate education and demonstration in people with Colorectal Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site 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 3 inclusion and 5 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 23 Jun 2021). 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?
Initial CRC Screening (time frame: 6 months after receipt of FIT kit). The study lists 3 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 NCT02360605, which also lists 26 linked publications.
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 30 Jun 2021.