Colorectal CancerNCT03200366
Comparing Interventions to Increase Colorectal Cancer Screening
A study testing Tailored DVD and Patient Navigation in people with Colorectal Cancer, run by Indiana University at 2 sites in United States.
Trial summary
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about 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?
- Tailored DVD and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2017to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
Who cannot join
- Unable to speak, read, and write English
- Personal history of CRC or polyps
- Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer
- Family history of CRC which increases the participant's risk for CRC
- Advised by a health care provider to not have a colonoscopy due to the participant's health
- Speech impairment
Show all 9Show fewer
- Hearing impairment
- Cognitive impairment
- Vision impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
Official title: Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.
Read the detailed description
Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings.
- Conditions
- Colorectal Cancer
- Being tested
- Tailored DVD, Patient Navigation
- Keywords
- Cancer Screening Tests, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored DVDBehavioural
A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.
Patient NavigationBehavioural
Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.
| Study group | Role | What they receive |
|---|---|---|
| Tailored DVD | Active comparator | Tailored digital video disc (DVD) Receives: Behavioral: Tailored DVD |
| Tailored DVD + Patient Navigation | Active comparator | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system Receives: Behavioral: Tailored DVD; Behavioral: Patient Navigation |
| Usual Care | No intervention | Care normally provided by a nurse in the endoscopy department of the healthcare system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Completing CRC Screening Per Electronic Medical Record Documentation
Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.
Measured: 12 months post-baseline interview
Secondary outcomes (18)
Participants Completing Colonoscopy Per Electronic Medical Record Documentation
Number of participants completing a colonoscopy is measured by electronic medical record review (EMR). Dates that participants completed a colonoscopy are extracted from the EMR.
Measured: 12 months post-baseline interview
Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale
Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS). BBPS scores the total quality on a 10 point scale from 0-9. Higher scores indicate better quality of bowel preparation.
Measured: 12 months post-baseline interview
Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale
Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale. The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor. Some endoscopists choose to grade quality more generally as adequate vs. inadequate. To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings). Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is scored as 0.
Measured: 12 months post-baseline interview
Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy
Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety.
Measured: 12 months post-baseline interview
Satisfaction With Colonoscopy Experience
Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team. Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied. Scores range from 1 to 4 with higher scores indicating greater satisfaction.
Measured: 12 months post-baseline interview
Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation
Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR.
Measured: 12 months post-baseline interview
Participants Who Self-Reported Completing CRC Screening
Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview.
Measured: 6-9 months post-baseline interview
Participants Who Self-Reported Completing a Colonoscopy
Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview.
Measured: 6-9 months post-baseline interview
Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)
Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview.
Measured: 6-9 months post-baseline interview
Change in Knowledge of CRC and Screening
Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests. The mean of the 9 items is calculated at baseline and 6 months post-baseline. Change from baseline equals the mean at 6 months minus the mean at baseline. Change can range from -9 to 9 with positive values indicating an increase in knowledge.
Measured: 6 months post-baseline interview
Change in Perceived Risk for CRC
Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely). Higher scores indicate a higher perceived risk for getting CRC. The mean of the 3 items is calculated at baseline and 6 months. Change in perceived risk equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived risk for getting CRC.
Measured: 6 months post-baseline interview
Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy
Change from baseline in colonoscopy-related procedural anxiety is measured at 6 months by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. The mean of the 6 items is calculated at baseline and 6 months post-baseline. Change from baseline is the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in anxiety.
Measured: 6 months post-baseline interview
Change in Perceived Benefits of CRC Screening by Colonoscopy
Change from baseline in perceived benefits of CRC screening by colonoscopy is measured at 6 months by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits of screening by colonoscopy.
Measured: 6 months post-baseline interview
Change in Perceived Barriers to CRC Screening by Colonoscopy
Change from baseline in perceived barriers to CRC screening by colonoscopy is measured at 6 months by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by colonoscopy.
Measured: 6 months post-baseline interview
Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy
Change from baseline in perceived self-efficacy for colonoscopy is measured at 6 months by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by colonoscopy. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by colonoscopy.
Measured: 6 months post-baseline interview
Change in Perceived Benefits of CRC Screening by FIT
Change from baseline in perceived benefits of CRC screening by FIT is measured at 6 months by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits for screening by FIT.
Measured: 6 months post-baseline interview
Change in Perceived Barriers to CRC Screening by FIT
Change from baseline in perceived barriers to CRC screening by FIT is measured at 6 months by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by FIT.
Measured: 6 months post-baseline interview
Change in Perceived Self-Efficacy for CRC Screening by FIT
Change from baseline in perceived self-efficacy for CRC screening by FIT is measured at 6 months by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by FIT. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by FIT.
Measured: 6 months post-baseline interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start26 Jul 2017
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Ohio State University
- Responsible party
- Principal investigator, Susan Rawl, Indiana University
- Investigators
- Susan M Rawl, PhD,RN, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200366
- Sponsor's protocol ID
- 1605880142
- Other IDs
- IHS-1507-31333
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2017
- Last updated
- 13 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A copy of the complete, cleaned, de-identified data set used to conduct the final analyses will be made available in SAS and SPSS formats.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
- ClinicalTrials.gov ID
- NCT03200366
- Acronym / sponsor ID
- 1605880142
- Conditions
- Colorectal Cancer
- Keywords
- Cancer Screening Tests, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Ohio State University
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.
Detailed description
Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored DVD | Active comparator | Behavioral: Tailored DVDTailored digital video disc (DVD) |
| Tailored DVD + Patient Navigation | Active comparator | Behavioral: Tailored DVD, Behavioral: Patient NavigationTailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system |
| Usual Care | No intervention | –Care normally provided by a nurse in the endoscopy department of the healthcare system |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
Key exclusion criteria (9 listed)
- Unable to speak, read, and write English
- Personal history of CRC or polyps
- Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer
- Family history of CRC which increases the participant's risk for CRC
- Advised by a health care provider to not have a colonoscopy due to the participant's health
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 |
|---|---|---|
| Tailored DVDA 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. | Behavioural | Tailored DVD, Tailored DVD + Patient Navigation |
| Patient NavigationParticipants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. | Behavioural | Tailored DVD + Patient Navigation |
Primary outcome
Participants Completing CRC Screening Per Electronic Medical Record Documentation
Time frame: 12 months post-baseline interview
Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.
18 secondary outcomes
Participants Completing Colonoscopy Per Electronic Medical Record Documentation
Time frame: 12 months post-baseline interview
Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale
Time frame: 12 months post-baseline interview
Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale
Time frame: 12 months post-baseline interview
Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy
Time frame: 12 months post-baseline interview
Satisfaction With Colonoscopy Experience
Time frame: 12 months post-baseline interview
Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation
Time frame: 12 months post-baseline interview
Participants Who Self-Reported Completing CRC Screening
Time frame: 6-9 months post-baseline interview
Participants Who Self-Reported Completing a Colonoscopy
Time frame: 6-9 months post-baseline interview
Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)
Time frame: 6-9 months post-baseline interview
Change in Knowledge of CRC and Screening
Time frame: 6 months post-baseline interview
Change in Perceived Risk for CRC
Time frame: 6 months post-baseline interview
Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy
Time frame: 6 months post-baseline interview
Change in Perceived Benefits of CRC Screening by Colonoscopy
Time frame: 6 months post-baseline interview
Change in Perceived Barriers to CRC Screening by Colonoscopy
Time frame: 6 months post-baseline interview
Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy
Time frame: 6 months post-baseline interview
Change in Perceived Benefits of CRC Screening by FIT
Time frame: 6 months post-baseline interview
Change in Perceived Barriers to CRC Screening by FIT
Time frame: 6 months post-baseline interview
Change in Perceived Self-Efficacy for CRC Screening by FIT
Time frame: 6 months post-baseline interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A copy of the complete, cleaned, de-identified data set used to conduct the final analyses will be made available in SAS and SPSS formats.
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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.
Susan M Rawl, PhD,RN principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored DVD and Patient Navigation in people with Colorectal Cancer, run by Indiana University 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 1 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 13 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants Completing CRC Screening Per Electronic Medical Record Documentation (time frame: 12 months post-baseline interview). 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 13 Sep 2021.