Colorectal CancerNCT05012007
Reminder Modality for CRC Screening
A study testing Reminder Phone and Reminder Text in people with Colorectal Cancer, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Reminder Phone and Reminder Text
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,653 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 26 Apr 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans 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 CRC screening
Who cannot join
- Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.
- No indication of current receipt of hospice care or record of recent death in the administrative data.
- No personal 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: Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial
This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.
Read the detailed description
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening.
Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions:
- Control arm: No reminder
- Intervention Type: No intervention
- Arm 2: Automated phone reminder
- Intervention Type: Standard reminder via phone (audiocare)
- Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
- Conditions
- Colorectal Cancer
- Being tested
- Reminder Phone, Reminder Text
- Keywords
- Cancer screening, 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.
Reminder PhoneOther
Standard reminder via phone (audiocare)
Reminder TextOther
reminder via text (VEText)
| Study group | Role | What they receive |
|---|---|---|
| Control arm: No Reminder | No intervention | Usual care |
| Automated phone reminder | Experimental | Standard reminder via phone (audiocare) Receives: Other: Reminder Phone |
| Text reminder | Experimental | Standard reminder via text (VEText) Receives: Other: Reminder Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of returned FIT Kits
the return rate at three months post randomization
Measured: three months post randomization
Secondary outcomes (1)
Percentage of returned FIT Kits
the return rate at six months post randomization
Measured: six months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Aug 2021
- Primary completion1 Mar 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,653 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
- NCT05012007
- Sponsor's protocol ID
- FIT2
- Status last verified
- May 2022
- First submitted
- 22 Jun 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deeds S, Schuttner L, Wheat C, Gunnink E, Geyer J, Beste L, Chen A, Dominitz JA, Nelson K, Reddy A. Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial. J Gen Intern Med. 2024 Jan;39(1):113-119. doi: 10.1007/s11606-023-08409-8. Epub 2023 Sep 20.
PubMed 37731137
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05012007
- Acronym / sponsor ID
- FIT2
- Conditions
- Colorectal Cancer
- Keywords
- Cancer screening, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,653 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 19 Aug 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 randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.
Detailed description
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening.
Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions:
- Control arm: No reminder
- Intervention Type: No intervention
- Arm 2: Automated phone reminder
- Intervention Type: Standard reminder via phone (audiocare)
- Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm: No Reminder | No intervention | –Usual care |
| Automated phone reminder | Experimental | Other: Reminder PhoneStandard reminder via phone (audiocare) |
| Text reminder | Experimental | Other: Reminder TextStandard reminder via text (VEText) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans 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 CRC screening
Key exclusion criteria (3 listed)
- Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.
- No indication of current receipt of hospice care or record of recent death in the administrative data.
- No personal 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 |
|---|---|---|
| Reminder PhoneStandard reminder via phone (audiocare) | Other | Automated phone reminder |
| Reminder Textreminder via text (VEText) | Other | Text reminder |
Primary outcome
Percentage of returned FIT Kits
Time frame: three months post randomization
the return rate at three months post randomization
1 secondary outcome
Percentage of returned FIT Kits
Time frame: six months post randomization
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 4 May 2022.
- Derived from this study: PubMed 37731137Deeds S, Schuttner L, Wheat C, Gunnink E, Geyer J, Beste L, Chen A, Dominitz JA, Nelson K, Reddy A. Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial. J Gen Intern Med. 2024 Jan;39(1):113-119. doi: 10.1007/s11606-023-08409-8. Epub 2023 Sep 20.
- 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.
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 Reminder Phone and Reminder Text 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 3 inclusion and 3 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 4 May 2022. 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?
Percentage of returned FIT Kits (time frame: three months post randomization). 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 NCT05012007, which also lists 1 linked publication.
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 4 May 2022.