Colorectal CancerPROMPTNCT03167125
Participatory Research to Advance Colon Cancer Prevention
A study testing Automated Prompts and Automated Plus Live Prompts in people with Colorectal Cancer, run by Kaiser Permanente at 1 site in United States.
Trial summary
The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases. 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 Prompts and Automated Plus Live Prompts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,580 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 30 Jun 2021
- 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
- Persons aged 50-75 years and not up-to-date with colorectal cancer screening
Who cannot join
- Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
AltaMed Health Services
Los Angeles, California, 90040
About this study
The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.
In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.
Read more
In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.
Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.
Read the detailed description
The study will fulfill the following aims:
Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.
Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.
In addition to Usual Care, the arms are:
- Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
- Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.
Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.
- Conditions
- Colorectal Cancer
- Being tested
- Automated Prompts, Automated Plus Live Prompts
- Keywords
- colorectal cancer screening, cancer screening, pragmatic trial, boot camp translation
- 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 PromptsOther
This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
Automated Plus Live PromptsOther
This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
| Study group | Role | What they receive |
|---|---|---|
| Automated Prompts | Active comparator | Patients randomized to this arm will receive automated prompts to complete and return the FIT kit. Receives: Other: Automated Prompts |
| Automated Plus Live Prompts | Active comparator | Patients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit. Receives: Other: Automated Plus Live Prompts |
| Usual Care | No intervention | Patients randomized to this arm will receive usual care screening opportunities per recommended colorectal cancer screening guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased colorectal cancer screening rates
Fecal testing completion
Measured: Up to 4 years (study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start5 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3) Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)
- Masking
- None (open label)
- Enrolment
- 27,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, AltaMed Health Services Corporation
- Responsible party
- Sponsor
- Investigators
- Gloria Coronado, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167125
- Sponsor's protocol ID
- 1U01MD010665-01
- Acronym
- PROMPT
- Status last verified
- Apr 2022
- First submitted
- 24 May 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coronado GD, Nyongesa DB, Escaron AL, Petrik AF, Thompson JH, Smith D, Davis MM, Schneider JL, Rivelli JS, Laguna T, Leo MC. Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial. Cancer Epidemiol Biomarkers Prev. 2023 Nov 1;32(11):1608-1616. doi: 10.1158/1055-9965.EPI-23-0597.
PubMed 37566431Schneider JL, Rivelli JS, Vaughn KA, Thompson JH, Petrik AF, Escaron AL, Coronado GD. Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff. Transl Behav Med. 2023 Sep 28;13(10):757-767. doi: 10.1093/tbm/ibad025.
PubMed 37210075Davis MM, Schneider JL, Petrik AF, Miech EJ, Younger B, Escaron AL, Rivelli JS, Thompson JH, Nyongesa D, Coronado GD. Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff. Ann Fam Med. 2022 Mar-Apr;20(2):123-129. doi: 10.1370/afm.2772.
PubMed 35346927Coronado GD, Nyongesa DB, Petrik AF, Thompson JH, Escaron AL, Younger B, Harbison S, Leo MC. Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2353-2360.e2. doi: 10.1016/j.cgh.2020.07.053. Epub 2020 Jul 30.
PubMed 32739569Coronado GD, Thompson JH, Petrik AF, Nyongesa DB, Leo MC, Castillo M, Younger B, Escaron A, Chen A. Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study. J Am Board Fam Med. 2019 May-Jun;32(3):318-328. doi: 10.3122/jabfm.2019.03.180275.
PubMed 31068396Thompson JH, Davis MM, Leo MC, Schneider JL, Smith DH, Petrik AF, Castillo M, Younger B, Coronado GD. Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial. Contemp Clin Trials. 2018 Apr;67:11-15. doi: 10.1016/j.cct.2018.02.001. Epub 2018 Feb 9.
PubMed 29408304
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Research to Advance Colon Cancer Prevention
- ClinicalTrials.gov ID
- NCT03167125
- Acronym / sponsor ID
- PROMPT / 1U01MD010665-01
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, cancer screening, pragmatic trial, boot camp translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,580 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, AltaMed Health Services Corporation
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 May 2017 (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.
The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.
In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.
In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.
Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.
Detailed description
The study will fulfill the following aims:
Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.
Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.
In addition to Usual Care, the arms are:
- Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
- Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.
Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3) Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)
| Arm | Type | Receives |
|---|---|---|
| Automated Prompts | Active comparator | Other: Automated PromptsPatients randomized to this arm will receive automated prompts to complete and return the FIT kit. |
| Automated Plus Live Prompts | Active comparator | Other: Automated Plus Live PromptsPatients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit. |
| Usual Care | No intervention | –Patients randomized to this arm will receive usual care screening opportunities per recommended colorectal cancer screening guidelines. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons aged 50-75 years and not up-to-date with colorectal cancer screening
Key exclusion criteria (1 listed)
- Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.
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 PromptsThis intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers. | Other | Automated Prompts |
| Automated Plus Live PromptsThis intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers. | Other | Automated Plus Live Prompts |
Primary outcome
Increased colorectal cancer screening rates
Time frame: Up to 4 years (study period)
Fecal testing completion
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 5 Apr 2022.
- Derived from this study: PubMed 37566431Coronado GD, Nyongesa DB, Escaron AL, Petrik AF, Thompson JH, Smith D, Davis MM, Schneider JL, Rivelli JS, Laguna T, Leo MC. Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial. Cancer Epidemiol Biomarkers Prev. 2023 Nov 1;32(11):1608-1616. doi: 10.1158/1055-9965.EPI-23-0597.
- Derived from this study: PubMed 37210075Schneider JL, Rivelli JS, Vaughn KA, Thompson JH, Petrik AF, Escaron AL, Coronado GD. Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff. Transl Behav Med. 2023 Sep 28;13(10):757-767. doi: 10.1093/tbm/ibad025.
- Derived from this study: PubMed 35346927Davis MM, Schneider JL, Petrik AF, Miech EJ, Younger B, Escaron AL, Rivelli JS, Thompson JH, Nyongesa D, Coronado GD. Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff. Ann Fam Med. 2022 Mar-Apr;20(2):123-129. doi: 10.1370/afm.2772.
- Derived from this study: PubMed 32739569Coronado GD, Nyongesa DB, Petrik AF, Thompson JH, Escaron AL, Younger B, Harbison S, Leo MC. Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2353-2360.e2. doi: 10.1016/j.cgh.2020.07.053. Epub 2020 Jul 30.
- Derived from this study: PubMed 31068396Coronado GD, Thompson JH, Petrik AF, Nyongesa DB, Leo MC, Castillo M, Younger B, Escaron A, Chen A. Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study. J Am Board Fam Med. 2019 May-Jun;32(3):318-328. doi: 10.3122/jabfm.2019.03.180275.
- Derived from this study: PubMed 29408304Thompson JH, Davis MM, Leo MC, Schneider JL, Smith DH, Petrik AF, Castillo M, Younger B, Coronado GD. Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial. Contemp Clin Trials. 2018 Apr;67:11-15. doi: 10.1016/j.cct.2018.02.001. Epub 2018 Feb 9.
- 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.
Gloria Coronado, PhD principal investigator
Kaiser Permanente
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 Prompts and Automated Plus Live Prompts in people with Colorectal Cancer, run by Kaiser Permanente 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 1 inclusion and 1 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 5 Apr 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?
Increased colorectal cancer screening rates (time frame: Up to 4 years (study period)). 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 NCT03167125, which also lists 6 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 5 Apr 2022.