Colorectal CancerNCT04923646
Veteran Primers for CRC Screening
A study testing Primer in people with Colorectal Cancer, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. 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?
- Primer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,404 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Veteran
- Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
- At least 1 year of prior data available (evidence of at least one outpatient visit)
- Due for annual colorectal (CRC) screening
Who cannot join
- Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
- Not currently receiving hospice care
- No record of recent death in the administrative data.
- No history of CRC or history of prior colectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).
Read the detailed description
Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:
- Active arm: Primer
- Intervention Type: Other
- Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
- Control arm: No primer a. Intervention Type: No intervention
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.
- Conditions
- Colorectal Cancer
- Being tested
- Primer
- Keywords
- Cancer screening, Behavioral economics, Adherence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimerOther
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Primer Receives: Other: Primer |
| Control | No intervention | No Primer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return proportion
Percent of returned FIT tests
Measured: 3 months
Secondary outcomes (1)
Return proportion
Percent of returned FIT tests
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start30 Jun 2021
- Primary completion1 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alaina Mori, VA Puget Sound Health Care System
- Investigators
- Ashok Reddy, MD, Principal investigator, VA Puget Sound Health Care SystemStefanie Deeds, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923646
- Sponsor's protocol ID
- FIT1
- Status last verified
- Jan 2024
- First submitted
- 19 May 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04923646
- Acronym / sponsor ID
- FIT1
- Conditions
- Colorectal Cancer
- Keywords
- Cancer screening, Behavioral economics, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,404 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).
Detailed description
Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:
- Active arm: Primer
- Intervention Type: Other
- Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
- Control arm: No primer a. Intervention Type: No intervention
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: PrimerPrimer |
| Control | No intervention | –No Primer |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
- At least 1 year of prior data available (evidence of at least one outpatient visit)
- Due for annual colorectal (CRC) screening
Key exclusion criteria (4 listed)
- Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
- Not currently receiving hospice care
- No record of recent death in the administrative data.
- No history of CRC or history of prior colectomy.
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 |
|---|---|---|
| PrimerMailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening. | Other | Active |
Primary outcome
Return proportion
Time frame: 3 months
Percent of returned FIT tests
1 secondary outcome
Return proportion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
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.
Ashok Reddy, MD principal investigator
VA Puget Sound Health Care System
Stefanie Deeds, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primer in people with Colorectal Cancer, run by VA Puget Sound Health Care System 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 4 inclusion and 4 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 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Return proportion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2024.