Colorectal Cancer
Conditions
Keywords
colorectal cancer screening, low literacy, community clinics, Fecal Immunochemical Test
Brief 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. 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.
Interventions
BEHAVIORALautomated telephone reminder
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.
BEHAVIORALprevention coordinator
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.
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.
Sponsors
Northwestern University
Loyola University
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial CRC Screening | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from February 2015-October 2016 in four Federally Qualified Health Centers in rural South Louisiana. Clinic staff asked consecutive patients aged 50 to 75 presenting to the clinic for a scheduled routine primary care visit if they were interested in participating in a CRC screening study.
Participants by arm
| Arm | Count |
|---|---|
| Automated Telephone Reminder Arm 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.
automated telephone reminder: 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 reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1. | 308 |
| Prevention Coordinator Arm 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.
Prevention coordinator: 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 reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure. | 306 |
| Total | 614 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 8 |
| Overall Study | Withdrawal by Subject | 4 | 9 |
Baseline characteristics
| Characteristic | Prevention Coordinator Arm | Total | Automated Telephone Reminder Arm |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 6.3 | 58.4 years STANDARD_DEVIATION 6.1 | 58.3 years STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 196 Participants | 406 Participants | 210 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 109 Participants | 204 Participants | 95 Participants |
| Sex: Female, Male Female | 169 Participants | 334 Participants | 165 Participants |
| Sex: Female, Male Male | 137 Participants | 280 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 308 | 1 / 306 |
| other Total, other adverse events | 0 / 308 | 0 / 306 |
| serious Total, serious adverse events | 0 / 308 | 0 / 306 |
Outcome results
Primary
Initial CRC Screening
A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.
Time frame: 6 months after receipt of FIT kit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Telephone Reminder Arm | Initial CRC Screening | 213 Participants |
| Prevention Coordinator Arm | Initial CRC Screening | 205 Participants |
Comparison: FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.p-value: 0.61Mixed Models Analysis
Primary
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.
Time frame: between 12 and 18 months of previous screen, 2 years overall
Population: 620 participants enrolled - 6 withdrew the day after enrollment - 614 participants at baseline. Of these, 44 had a positive FIT result and were excluded from the second FIT screening and 2 withdrew after year 1 resulting in a sample size of 568 for the 2nd year screening analysis. All participants who were enrolled were included in the final analysis with the exception of the 44 with a positive FIT test in Year 1 and the 2 lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Telephone Reminder Arm | Repeat CRC Screening | 104 Participants |
| Prevention Coordinator Arm | Repeat CRC Screening | 95 Participants |
Comparison: Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.p-value: 0.3Mixed Models Analysis
Primary
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.
Time frame: between 12 and 18 months of previous screen, 2 years overall
Population: 531 eligible for year 3 screening - 614 baseline minus \[Year 1 FIT positive (n=44) + Lost to follow-up in year 2 (n=2) + Year 2 FIT positive (n=17) =Lost to follow-up in year 3 (n=20)\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Telephone Reminder Arm | Repeat Screening | 58 Participants |
| Prevention Coordinator Arm | Repeat Screening | 58 Participants |
Comparison: Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.p-value: 0.97Mixed Models Analysis