Colorectal CancerAIMSSNCT03100461
Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
A study testing I2 and Health Education in people with Colorectal Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this study is to find the best ways to increase colorectal cancer (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?
- I2 and Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 30 Sep 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
- Have a home address and access to a working telephone
- Pass Mini-Cog assessment
Who cannot join
- FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
- Acute medical illness,
- current GI bleed
- history of adenomatous polyps
- Colorectal Cancer
- 1st degree relative with CRC < age 60 years
Show all 9Show fewer
- inherited polyposis/non-polyposis syndrome
- inflammatory bowel disease
- Another household member enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.
Read the detailed description
Colorectal Cancer is preventable and curable but is still the second most common cause of cancer death in the U.S. Minorities and those with low income have more CRC than middle and high income Whites.. They also get fewer CRC screening tests. Low knowledge of CRC screening may, in part, drive this lower test use. We need new ways to improve CRC screening in primary care clinics where many minority and uninsured patients receive health care.
- Conditions
- Colorectal Cancer
- Being tested
- I2, Health Education
- Keywords
- Cancer Screening, Colon Cancer, Colon Cancer Screening
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I2Other
Also called Implementation Intentions
A touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.).
Health EducationOther
Standard of care approach that will provide basic information on CRC screening.
| Study group | Role | What they receive |
|---|---|---|
| HE + HE | Active comparator | Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months. Receives: Other: Health Education |
| HE + I2 | Active comparator | Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months. Receives: Other: I2; Other: Health Education |
| I2 + I2 | Experimental | Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months. Receives: Other: I2 |
| I2 + HE | Active comparator | Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months. Receives: Other: I2; Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion rate
Rate of participants who receive CRC screening during study participation
Measured: 12-14 Months
Secondary outcomes (1)
Cost analysis of each intervention pathway
Measure will be calculated by estimating all cost factors in the CRC screening process, include personnel and materials/supplies costs, materials development costs, and time of all study staff involved. Measure represented as a per participant cost to complete screening.
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start22 Jan 2018
- Primary completion31 Aug 2022
- Study completion30 Sep 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Allen Greiner, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100461
- Sponsor's protocol ID
- STUDY00002929
- Other IDs
- 1R01CA188898-01A1
- Acronym
- AIMSS
- Status last verified
- May 2020
- First submitted
- 29 Mar 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
- ClinicalTrials.gov ID
- NCT03100461
- Acronym / sponsor ID
- AIMSS / STUDY00002929
- Conditions
- Colorectal Cancer
- Keywords
- Cancer Screening, Colon Cancer, Colon Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Apr 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 goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.
Detailed description
Colorectal Cancer is preventable and curable but is still the second most common cause of cancer death in the U.S. Minorities and those with low income have more CRC than middle and high income Whites.. They also get fewer CRC screening tests. Low knowledge of CRC screening may, in part, drive this lower test use. We need new ways to improve CRC screening in primary care clinics where many minority and uninsured patients receive health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HE + HE | Active comparator | Other: Health EducationParticipants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months. |
| HE + I2 | Active comparator | Other: I2, Other: Health EducationParticipants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months. |
| I2 + I2 | Experimental | Other: I2Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months. |
| I2 + HE | Active comparator | Other: I2, Other: Health EducationParticipants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a home address and access to a working telephone
- Pass Mini-Cog assessment
Key exclusion criteria (9 listed)
- FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
- Acute medical illness,
- current GI bleed
- history of adenomatous polyps
- Colorectal Cancer
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 |
|---|---|---|
| I2Also: Implementation IntentionsA touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.). | Other | HE + I2, I2 + HE, I2 + I2 |
| Health EducationStandard of care approach that will provide basic information on CRC screening. | Other | HE + HE, HE + I2, I2 + HE |
Primary outcome
CRC screening completion rate
Time frame: 12-14 Months
Rate of participants who receive CRC screening during study participation
1 secondary outcome
Cost analysis of each intervention pathway
Time frame: 14 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 15 Oct 2024.
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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.
Allen Greiner, MD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I2 and Health Education in people with Colorectal Cancer, run by University of Kansas Medical 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 2 inclusion and 9 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 15 Oct 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?
CRC screening completion rate (time frame: 12-14 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 15 Oct 2024.