Colorectal CarcinomaNCT05291988
A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial
A study testing Educational Intervention, Fecal Immunochemical Test and Questionnaire Administration in people with Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial summary
This clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Educational Intervention, Fecal Immunochemical Test and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2022to 4 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45 years or older or < 45 years old with family history of CRC
- Speak and read English or Spanish
- Current resident in Clallam county
- Currently non-adherent to CRC screening recommendations
Who cannot join
- Age < 18 years old
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Olympic Medical Cancer Care Center
Sequim, Washington, 98384
About this study
Official title: A Multilevel Approach to Improving Colorectal Cancer Screening in Rural Communities of the FH/UW Catchment Area
This clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). These rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, Pap, and colorectal screening recommendations. This study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as "Screen to Save (S2S)" and a fecal immunochemical test (FIT) kit distribution are acceptable and accessible to patients. FIT kits may help doctors find colorectal cancer sooner, when it may be easier to treat.
Read the detailed description
OUTLINE:
Participants receive S2S online screening education and FIT kit for sample collection.
After completion of study intervention, patients are followed up at 3 months.
- Conditions
- Colorectal Carcinoma
- Being tested
- Educational Intervention, Fecal Immunochemical Test, Questionnaire Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive S2S education
Fecal Immunochemical TestOther
Also called FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test
Receive FIT kit
Questionnaire AdministrationOther
Ancillary Studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (S2S education, FIT kit) | Experimental | Participants receive S2S online screening education and FIT kit for sample collection. Receives: Other: Educational Intervention; Other: Fecal Immunochemical Test; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessibility
Three questions will be asked post-intervention to assess fit of the screen to save (S2S) education, suitability, and usefulness of the useful for learning about colorectal cancer (CRC) and CRC screening.
Measured: Up to 3 months
Acceptability
Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
Measured: Up to 3 months
Participant uptake
Feasibility evaluation will include assessment of the number of participants that respond to the letter of invitation to 1) participate in the educational portion of the project by viewing the online S2S education and completing the online questionnaires and 2) complete the pick-up and return of the FIT Kit. This will be assessed through participant tracking and follow-up procedures.
Measured: Up to 3 months
Demographic information
The following demographic information will be collected: participant's age, gender, race/ethnicity, preferred language, household income, highest level of education, insurance status, ZIP code, country of origin, and years of United States (U.S.) residence. Demographics will be analyzed within each group using Chi-square or Fisher's exact test for paired binary data.
Measured: At pre-intervention only
Secondary outcomes (5)
Colorectal cancer knowledge
Knowledge will be assessed pre- and post-intervention. The knowledge scale will include 5 multiple choice knowledge questions about colorectal screening and colorectal cancer presented as part of the S2S inflatable colon education.
Measured: Up to 3 months
Behavioral intention
Intention to get CRC screening will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely).
Measured: Up to 3 months
Social engagement
Social engagement likelihood will be measure using a single question about their intention to share information learned during the S2S education with others (parents, grandparents, relatives, peers, community members).
Measured: Up to 3 months
Medical and colorectal cancer information
Use of regular health clinic and medical providers, history of colorectal cancer screening, and family and personal history of colorectal cancer diagnosis.
Measured: At pre-intervention
COVID-19 impact assessment
A single question about the impact of COVID-19 on the decision to get colorectal cancer screening will determine if non-adherence was related to COVID-19. A yes/no response will be required.
Measured: At pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start8 Oct 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Why it stopped: Terminated due to low accrual
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Ceballos, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291988
- Sponsor's protocol ID
- RG1121686
- Other IDs
- NCI-2022-01172, 10786
- Status last verified
- Dec 2022
- First submitted
- 14 Mar 2022
- Last updated
- 15 Dec 2022
- 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Approach to Improving Colorectal Cancer Screening in Rural Communities of the FH/UW Catchment Area
- ClinicalTrials.gov ID
- NCT05291988
- Acronym / sponsor ID
- RG1121686
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 23 Mar 2022 (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 determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). These rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, Pap, and colorectal screening recommendations. This study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as "Screen to Save (S2S)" and a fecal immunochemical test (FIT) kit distribution are acceptable and accessible to patients. FIT kits may help doctors find colorectal cancer sooner, when it may be easier to treat.
Detailed description
OUTLINE:
Participants receive S2S online screening education and FIT kit for sample collection.
After completion of study intervention, patients are followed up at 3 months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (S2S education, FIT kit) | Experimental | Other: Educational Intervention, Other: Fecal Immunochemical Test, Other: Questionnaire AdministrationParticipants receive S2S online screening education and FIT kit for sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45 years or older or < 45 years old with family history of CRC
- Speak and read English or Spanish
- Current resident in Clallam county
- Currently non-adherent to CRC screening recommendations
Key exclusion criteria (1 listed)
- Age < 18 years old
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive S2S education | Other | Screening (S2S education, FIT kit) |
| Fecal Immunochemical TestAlso: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood testReceive FIT kit | Other | Screening (S2S education, FIT kit) |
| Questionnaire AdministrationAncillary Studies | Other | Screening (S2S education, FIT kit) |
Primary outcome
Accessibility
Time frame: Up to 3 months
Three questions will be asked post-intervention to assess fit of the screen to save (S2S) education, suitability, and usefulness of the useful for learning about colorectal cancer (CRC) and CRC screening.
Acceptability
Time frame: Up to 3 months
Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
Participant uptake
Time frame: Up to 3 months
Feasibility evaluation will include assessment of the number of participants that respond to the letter of invitation to 1) participate in the educational portion of the project by viewing the online S2S education and completing the online questionnaires and 2) complete the pick-up and return of the FIT Kit. This will be assessed through participant tracking and follow-up procedures.
Demographic information
Time frame: At pre-intervention only
The following demographic information will be collected: participant's age, gender, race/ethnicity, preferred language, household income, highest level of education, insurance status, ZIP code, country of origin, and years of United States (U.S.) residence. Demographics will be analyzed within each group using Chi-square or Fisher's exact test for paired binary data.
5 secondary outcomes
Colorectal cancer knowledge
Time frame: Up to 3 months
Behavioral intention
Time frame: Up to 3 months
Social engagement
Time frame: Up to 3 months
Medical and colorectal cancer information
Time frame: At pre-intervention
COVID-19 impact assessment
Time frame: At pre-intervention
Results and safety
The study was stopped early (reason given: Terminated due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- 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.
Rachel Ceballos principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Fecal Immunochemical Test and Questionnaire Administration in people with Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites 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 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: stopped early, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Terminated due to low accrual). Results are not available in the source record.
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?
Accessibility (time frame: Up to 3 months). The study lists 4 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 15 Dec 2022.