Colorectal CarcinomaNCT06822530
A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Best Practice, Educational Intervention and Electronic Health Record Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- PATIENTS: Age >= 45 years old and =< 75 years old
- PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
- PATIENTS: >= 1 month from documented abnormal FIT result
- PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
- CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care
- CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)/UW Medicine Population Health Program that provide colorectal cancer screening and navigation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Rachel B. Issaka, MD, MAS, 206-667-1447, rissaka@fredhutch.org
Rachel B. Issaka, MD, MAS
About this study
Official title: PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions
This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.
GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse.
After completion of study intervention, patients are followed up for 18 months.
- Conditions
- Colorectal Carcinoma
- Being tested
- Best Practice, Educational Intervention, Electronic Health Record Review, Interview, Supportive Care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care CRC screening program navigation
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive QR code and link to video addressing fears of colonoscopy
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive rideshare transportation home after colonoscopy
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (usual care) | Active comparator | Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling. Receives: Other: Best Practice; Other: Electronic Health Record Review |
| Group II (usual care, video, rideshare transportation) | Experimental | Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study. Receives: Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Supportive Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of colonoscopy completion within 6 months
Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).
Measured: At 6 months after randomization
Time to colonoscopy completion
Will assess the time to colonoscopy completion in days and compare these times across individual clinics.
Measured: Beginning 6 months after randomization until study completion
Secondary outcomes (15)
Rate of colonoscopy completion > 6 months
Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.
Measured: At 9 and 12 months after randomization
Colonoscopy referral: Number of participants referred for a colonoscopy
Will assess colonoscopy referral (yes/no) as the number of participants who have a colonoscopy referral placed after randomization.
Measured: Up to 18 months after randomization
Time to colonoscopy referral (days)
Will assess the number of days from randomization to colonoscopy referral.
Measured: Up to 18 months after randomization
Number of participants who schedule a colonoscopy
Will assess the number of referred participants who schedule a colonoscopy.
Measured: Up to 18 months after randomization
Time to scheduling a colonoscopy (days)
Will assess the number of days from randomization to a colonoscopy being scheduled.
Measured: Up to 18 months after randomization
Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion
Will assess the time from abnormal FIT results to colonoscopy completion (days). Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. For time-to-event secondary outcomes, will fit separate Cox proportional hazards regression models where the outcomes will be measured in days. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.
Measured: Up to 18 months after randomization
Rates of colorectal cancer or advanced adenoma
Will assess the number of colorectal cancers or advanced adenomas detected as reported in pathology reports. Colorectal cancer will be defined as a histologically confirmed invasive carcinoma or minimally invasive carcinoma. Advanced adenoma will be defined as a tubular adenoma > or = 10mm, villous, or high-grade dysplasia.
Measured: Up to 18 months after randomization
Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)
Participant demographics and quantitative measures of implementation outcomes (reach) will be reported as proportions or medians and interquartile ranges (IQRs). Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate.
Measured: 6-24 months post randomization
Perception that the intervention components are suitable to address identified barriers (Acceptability)
Participant demographics and quantitative measures of implementation outcomes (acceptability) will be reported as proportions or medians and IQRs. Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate. Semi-structured interviews will be transcribed verbatim, verified against recordings, and uploaded to the data management software by participant number. Will apply a hybrid approach to the data analysis by combining inductive and deductive methods. Using a convergent parallel mixed-methods approach, will integrate and analyze quantitative and qualitative data, according to the Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation model that analyzes data at multiple ecological levels and is particularly relevant for the study.
Measured: 6-24 months post randomization
Degree to which the intervention is used as intended (Fidelity)
Will be assessed by the proportion and demographic characteristics of individuals who use all components of the intervention after randomization, complete adherence to the program protocol, and quality of the program delivery. Participant demographics and quantitative measures of implementation outcomes (fidelity) will be reported as proportions or medians and IQRs. Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate.
Measured: 6-24 months post randomization
Average cost per patient to deliver the intervention
Will calculate personnel and operational costs for the multilevel intervention for each patient. Total costs for each component per patient (personnel, materials/supplies, facility fees, training, and professional development) will also be calculated.
Measured: Weekly, for up to 8 months
Average cost per clinic to deliver the intervention
Will calculate personnel and operational costs for the multilevel intervention for each clinic. Total costs for each component per clinic (personnel, materials/supplies, facility fees, training, and professional development) will also be calculated.
Measured: Weekly, for up to 8 months
Proportion of costs per intervention activity
Will calculate the proportion of costs that can be attributed to each intervention activity.
Measured: Weekly, for up to 8 months
Number of participants served per intervention component
The number of participants served per intervention component.
Measured: Weekly, for up to 8 months
Average cost per participant by intervention component
Will calculate an average per-participant activity cost for each intervention component.
Measured: Weekly, for up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start16 Dec 2025
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 682 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rachel B. Issaka, MD, MAS, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822530
- Sponsor's protocol ID
- RG1124701
- Other IDs
- NCI-2024-08639, R37CA295618, FHIRB0020712
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared with other researchers: All of the IPD collected during the trial, after deidentification. Supporting information that will be shared will include: Study protocol, analyzable data set, data dictionary/codebook, statistical analysis plan, analytic code, data collection instruments.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions
- ClinicalTrials.gov ID
- NCT06822530
- Acronym / sponsor ID
- RG1124701
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 682 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 12 Feb 2025 (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 clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.
GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse.
After completion of study intervention, patients are followed up for 18 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (usual care) | Active comparator | Other: Best Practice, Other: Electronic Health Record ReviewPatients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling. |
| Group II (usual care, video, rideshare transportation) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Interview, Other: Supportive Care, Other: Survey AdministrationPatients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PATIENTS: Age >= 45 years old and =< 75 years old
- PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
- PATIENTS: >= 1 month from documented abnormal FIT result
- PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
- CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care CRC screening program navigation | Other | Group I (usual care), Group II (usual care, video, rideshare transportation) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive QR code and link to video addressing fears of colonoscopy | Other | Group II (usual care, video, rideshare transportation) |
| Electronic Health Record ReviewAncillary studies | Other | Group I (usual care), Group II (usual care, video, rideshare transportation) |
| InterviewAncillary studies | Other | Group II (usual care, video, rideshare transportation) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive rideshare transportation home after colonoscopy | Other | Group II (usual care, video, rideshare transportation) |
| Survey AdministrationAncillary studies | Other | Group II (usual care, video, rideshare transportation) |
Primary outcome
Rate of colonoscopy completion within 6 months
Time frame: At 6 months after randomization
Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).
Time to colonoscopy completion
Time frame: Beginning 6 months after randomization until study completion
Will assess the time to colonoscopy completion in days and compare these times across individual clinics.
15 secondary outcomes
Rate of colonoscopy completion > 6 months
Time frame: At 9 and 12 months after randomization
Colonoscopy referral: Number of participants referred for a colonoscopy
Time frame: Up to 18 months after randomization
Time to colonoscopy referral (days)
Time frame: Up to 18 months after randomization
Number of participants who schedule a colonoscopy
Time frame: Up to 18 months after randomization
Time to scheduling a colonoscopy (days)
Time frame: Up to 18 months after randomization
Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion
Time frame: Up to 18 months after randomization
Rates of colorectal cancer or advanced adenoma
Time frame: Up to 18 months after randomization
Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)
Time frame: 6-24 months post randomization
Perception that the intervention components are suitable to address identified barriers (Acceptability)
Time frame: 6-24 months post randomization
Degree to which the intervention is used as intended (Fidelity)
Time frame: 6-24 months post randomization
Average cost per patient to deliver the intervention
Time frame: Weekly, for up to 8 months
Average cost per clinic to deliver the intervention
Time frame: Weekly, for up to 8 months
Proportion of costs per intervention activity
Time frame: Weekly, for up to 8 months
Number of participants served per intervention component
Time frame: Weekly, for up to 8 months
Average cost per participant by intervention component
Time frame: Weekly, for up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. IPD to be shared with other researchers: All of the IPD collected during the trial, after deidentification. Supporting information that will be shared will include: Study protocol, analyzable data set, data dictionary/codebook, statistical analysis plan, analytic code, data collection instruments.
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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.
Rachel B. Issaka, MD, MAS principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Colorectal Carcinoma, run by Fred Hutchinson Cancer Center 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 6 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel B. Issaka, MD, MAS (206-667-1447, rissaka@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of colonoscopy completion within 6 months (time frame: At 6 months after randomization). The study lists 2 primary outcomes in all. 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 22 Jun 2026.