Implementation of mailed colon cancer screening testing
| ISRCTN | ISRCTN22187559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22187559 |
- Submission date
- 02/01/2024
- Registration date
- 08/01/2024
- Last edited
- 09/01/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
In the Veterans Health Administration, traditionally, colon cancer screening is offered only when a Veteran is seen by their provider. Therefore, if a Veteran does not regularly meet with their provider, they may not be screened for colon cancer or be under-screened. Mailed colon cancer screening testing (FIT kits) programs have been successfully implemented in select VAs in the U.S. Therefore, to improve cancer screening rates, the goal of this project is to evaluate if patients are more likely to complete colon cancer screening if they are mailed a home test kit.
Who can participate?
Veterans ages 45-75 living in the U.S.
What does the study involve?
A post-card will be mailed to eligible Veterans stating that they will be mailed a FIT kit and instructions. There will also be instructions on who to reach if they have had a colonoscopy elsewhere or wish no further contact. Two weeks later they will receive a packet that contains an information letter, instructions, FAQs and a FIT kit with a pre-addressed pre-paid return envelope. After 2 weeks, nonresponders will be called with a pre-recorded scripted phone call, reminding them to complete their FIT kit or call to schedule a colonoscopy. In another 2 weeks, non-responders will be mailed a final reminder letter to complete their FIT kit screening or call to schedule a colonoscopy. Two weeks after that, a templated note will be placed in their electronic health chart to alert their PCP that the Veteran did not respond to the multi-step screening invitation outreach and that they should proceed as they see best regarding screening that patient. If the Veteran mails their FIT kit back, it will be processed by the clinical lab.
What are the possible benefits and risks of participating?
Benefits are increased rates of colon cancer screening which can lead to catching colon cancer earlier thereby improving mortality. Additionally, many patients can complete colon cancer screening in the convenience of their home rather than requiring a colonoscopy. Risks include false positive results.
Where is the study run from?
Minneapolis VA Health Care System (USA)
When is the study starting and how long is it expected to run for?
February 2024 to March 2026
Who is funding the study?
U.S. Department of Veterans Affairs (USA)
Who is the main contact?
Susan Lou, MD, susan.lou2@va.gov
Contact information
Public, Scientific, Principal Investigator
1 Veterans Drive
Minneapolis
55417
United States of America
 ORCID ID |
0000-0003-0150-6487 |
|---|---|
| Phone | +1 612-467-4100 |
| susan.lou2@va.gov |
Study information
| Study design | Prospective pragmatic trial with 2 arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice, Home |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Implementation of mailed (faecal immunochemical test) FIT outreach |
| Study objectives | Patients that are sent a colonoscopy screening test in the mail will have increased completion of colon cancer screening compared to standard of care. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This project was submitted to the Minneapolis VA Institutional Review Board (IRB) and they determined on 30/11/2023 that, as a quality improvement project, it did not meet the definition of research and therefore did not require IRB oversight |
| Health condition(s) or problem(s) studied | Completion of colon cancer screening |
| Intervention | Patients who are average risk, asymptomatic, and due for colon cancer screening will be identified via a national VA cohort identification tool. Primary care providers will be split into two arms. Eligible patients of the primary care providers in arm "A" will receive the intervention while eligible patients of primary care providers in arm "B" will serve as the control. For those in the intervention arm, a post-card primer will be mailed to eligible Veterans stating that they will be mailed a FIT kit and instructions. There will also be instructions on who to reach if they have had a colonoscopy elsewhere, are not otherwise average risk, or wish no further contact. A “return service requested” will be enabled to track both undeliverable and changes of address. Two weeks after receiving the postcard, Veterans will receive a packet that contains an information letter, instructions, FAQs and a FIT kit with a pre-addressed, pre-paid return envelope. After 2 weeks, nonresponders will be called with a pre-recorded scripted phone call, reminding them to complete their FIT kit or call to schedule a colonoscopy. In another 2 weeks, non-responders will be mailed a final reminder letter to complete their FIT kit screening or call to schedule a colonoscopy. Two weeks after that, a templated note will be placed in their electronic health chart to alert their PCP that the Veteran did not respond to the multi-step screening invitation outreach, and that they should proceed as they see best regarding screening that patient. If the veteran mails their FIT kit back, it will be processed by the clinical lab. |
| Intervention type | Other |
| Primary outcome measure | Completion of colon cancer screening completion four weeks after being mailed a FIT kit measured using patient records |
| Secondary outcome measures | Reach of the intervention - proportion of patients that schedule a colonoscopy following a positive test measured using patient records at the end of the study |
| Overall study start date | 01/11/2023 |
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 9000 |
| Key inclusion criteria | 1. Is not deceased 2. Is a Veteran 3. Must have deliverable address 4. Active or pending primary care provider assignment |
| Key exclusion criteria | 1. Exclude patients from Northern Mariana Islands, Armed Forces Pacific, Palau, Virgin Islands, American Somoa, Armed Forces AF, EU, ME, CA, Puerto Rico, or any foreign country 2. CAN score with 1 year mortality rate of >50% 3. Have received hospice care in the last two years 4. Have received palliative care in the last year 5. Have had ulcerative colitis diagnosis in the last year 6. Have had crohn disease diagnosis in the last year 7. History of adeoma in the last year 8. Have had metastatic cancer diagnosis in the last year 9. Any total colectomy procedures in the last year 10. Frailty and advanced illness diagnosis in the last year 11. Clopidogrel (or other thienopyridine) prescription in the last four months of prescription and no prescription for 121-365 days prior 12. Have had FOBT in the last 10 months 13. Have had colonoscopy in the last 112 months 14. Have had a CT colonography in the last 54 months 15. Have had a DNA FIT in the last 33 months 16. Have had a Flex Sigmoid in the last 4.5 years 17. Active/pending/scheduled colonoscopy consults in the last 90 days 18. Have existing mailed FIT orders |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 02/01/2026 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Minneapolis
55417
United States of America
Sponsor information
Hospital/treatment centre
One Veterans Drive
Minneapolis
55417
United States of America
| Phone | +1 612-467-5655 |
|---|---|
| julie.toth@va.gov | |
| Website | http://www.minneapolis.va.gov/ |
"ROR" |
https://ror.org/02ry60714 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Veterans Affairs, United States Department of Veterans Affairs, US Department of Veterans Affairs, U.S. Dept. of Veterans Affairs, Veterans Affairs, Veterans Affairs Department, VA, USDVA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
09/01/2024: The public title was changed from "Implementation of mailed colonoscopy screening testing" to "Implementation of mailed colon cancer screening testing".
08/01/2024: Internal review.
04/01/2024: Study's existence confirmed by the Minneapolis VA Health Care System.
