Colorectal CarcinomaNCT05458986
A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test
A study testing Media Intervention, Best Practice and Questionnaire Administration in people with Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Media Intervention, Best Practice and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 3 May 2024
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-75
- Have an assigned primary care provider in our partnering safety-net health system
- Have a billable primary care encounter between 2019-2022
- Have an abnormal FIT result for colorectal cancer (CRC) screening without a colonoscopy within 1 year
- Ability to communicate in English due to initial videos being available in English
Who cannot join
- Adults < age 45 or > age 75
- Patients who receive care at other University of Washington (UW) medicine sites (non-safety-net patients)
- Individuals without a primary care encounter between 2019-2022
- Individuals whose primary language is not English
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Pilot Video Intervention to Decrease Fear of Colonoscopy in a Safety-Net Healthcare System
This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.
ARM 2: Patients receive usual care and do not watch the educational video.
After completion of study, patients are followed for 12 months after their abnormal FIT result.
- Conditions
- Colorectal Carcinoma
- Being tested
- Media Intervention, Best Practice, 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.
Media InterventionOther
Watch an educational video
Best PracticeOther
Receive usual care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (educational video) | Experimental | Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy. Receives: Other: Media Intervention; Other: Questionnaire Administration |
| Arm 2 (usual care) | Active comparator | Patients receive usual care and do not watch the educational video. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study accrual
Feasibility will be measured by recruitment as the proportion of invited participants who consent and complete the pilot study.
Measured: Up to 12 months post-abnormal fecal immunochemical test (FIT) result
Feasibility: number of contacts needed to reach target enrollment
Feasibility will be measured by recruitment as the number of contacts required to reach target enrollment.
Measured: Up to 12 months post-abnormal FIT result
Feasibility: time to reach recruitment
Feasibility will be measured by recruitment as the time required to reach target enrollment. Time to reach recruitment target will be measured in days and described using medians and interquartile range (IQR).
Measured: Up to 12 months post-abnormal FIT result
Acceptability of the video intervention assessed by a survey
Intervention arm patients will complete a post-intervention survey to assess acceptability of the intervention using the Acceptability of Intervention Measure (AIM), a 4-item measure. Items are rated on a 5-point Likert Scale (1, completely disagree; 5, completely agree). Mean scores will be calculated to generate an average AIM score, where higher scores will indicate higher levels of acceptability.
Measured: Up to 12 months post-abnormal FIT result
Incidence of fear related to colonoscopy
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about fear of colonoscopy. Usual care patients will complete a baseline survey on the same measures. Fear will be assessed using Manne's 6-item fear of colonoscopy scale. Items are rated on a 5-point Likert scale (1, not at all fearful; 5, extremely fearful). Mean scores will be calculated to generate average fear per participant, with higher scores indicating higher levels of fear.
Measured: Up to 12 months post-abnormal FIT result
Knowledge about colonoscopy
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about knowledge about colon cancer screening. Usual care patients will complete a baseline survey on the same measures. Knowledge will be measured using 8 validated questions. Incorrect answers will be scored as 0 and correct answers scored as 1. Higher scores will indicate higher levels of knowledge.
Measured: Up to 12 months post-abnormal FIT result
Self-efficacy related to colonoscopy
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about self-efficacy related to a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Self-efficacy will be assessed by adopting an 8-item self-efficacy scale for colonoscopy completion in patients with inflammatory bowel diseases and responses will be recorded on a 5-point scale. Higher scores will indicate higher levels of self-efficacy.
Measured: Up to 12 months post-abnormal FIT result
Intent to complete a colonoscopy
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about intent to complete a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Intent will be measured using a single validated question on a nominal scale with 5 options. Responses will be dichotomized to affirmative intent (definitely will do, will do) or uncertain intent (don't know, will not do, and definitely will not do).
Measured: Up to 12 months post-abnormal FIT result
Secondary outcomes (1)
Incidence of completed colonoscopies
Through review of the electronic health records (EHR), the investigators will determine rates of completed colonoscopy 6 months after randomization to assess preliminary efficacy.
Measured: At 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start15 May 2023
- Primary completion3 May 2024
- Study completion3 May 2024
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- Rachel Issaka, MD, MAS, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458986
- Sponsor's protocol ID
- RG1122309
- Other IDs
- NCI-2022-05223, 10950
- Status last verified
- May 2024
- First submitted
- 1 Jul 2022
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Video Intervention to Decrease Fear of Colonoscopy in a Safety-Net Healthcare System
- ClinicalTrials.gov ID
- NCT05458986
- Acronym / sponsor ID
- RG1122309
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- 15 May 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 14 Jul 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 compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.
ARM 2: Patients receive usual care and do not watch the educational video.
After completion of study, patients are followed for 12 months after their abnormal FIT result.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (educational video) | Experimental | Other: Media Intervention, Other: Questionnaire AdministrationPatients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy. |
| Arm 2 (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive usual care and do not watch the educational video. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 45-75
- Have an assigned primary care provider in our partnering safety-net health system
- Have a billable primary care encounter between 2019-2022
- Have an abnormal FIT result for colorectal cancer (CRC) screening without a colonoscopy within 1 year
- Ability to communicate in English due to initial videos being available in English
Key exclusion criteria (4 listed)
- Adults < age 45 or > age 75
- Patients who receive care at other University of Washington (UW) medicine sites (non-safety-net patients)
- Individuals without a primary care encounter between 2019-2022
- Individuals whose primary language is not English
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 |
|---|---|---|
| Media InterventionWatch an educational video | Other | Arm 1 (educational video) |
| Best PracticeReceive usual care | Other | Arm 2 (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (educational video), Arm 2 (usual care) |
Primary outcome
Feasibility as measured by study accrual
Time frame: Up to 12 months post-abnormal fecal immunochemical test (FIT) result
Feasibility will be measured by recruitment as the proportion of invited participants who consent and complete the pilot study.
Feasibility: number of contacts needed to reach target enrollment
Time frame: Up to 12 months post-abnormal FIT result
Feasibility will be measured by recruitment as the number of contacts required to reach target enrollment.
Feasibility: time to reach recruitment
Time frame: Up to 12 months post-abnormal FIT result
Feasibility will be measured by recruitment as the time required to reach target enrollment. Time to reach recruitment target will be measured in days and described using medians and interquartile range (IQR).
Acceptability of the video intervention assessed by a survey
Time frame: Up to 12 months post-abnormal FIT result
Intervention arm patients will complete a post-intervention survey to assess acceptability of the intervention using the Acceptability of Intervention Measure (AIM), a 4-item measure. Items are rated on a 5-point Likert Scale (1, completely disagree; 5, completely agree). Mean scores will be calculated to generate an average AIM score, where higher scores will indicate higher levels of acceptability.
Incidence of fear related to colonoscopy
Time frame: Up to 12 months post-abnormal FIT result
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about fear of colonoscopy. Usual care patients will complete a baseline survey on the same measures. Fear will be assessed using Manne's 6-item fear of colonoscopy scale. Items are rated on a 5-point Likert scale (1, not at all fearful; 5, extremely fearful). Mean scores will be calculated to generate average fear per participant, with higher scores indicating higher levels of fear.
Knowledge about colonoscopy
Time frame: Up to 12 months post-abnormal FIT result
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about knowledge about colon cancer screening. Usual care patients will complete a baseline survey on the same measures. Knowledge will be measured using 8 validated questions. Incorrect answers will be scored as 0 and correct answers scored as 1. Higher scores will indicate higher levels of knowledge.
Self-efficacy related to colonoscopy
Time frame: Up to 12 months post-abnormal FIT result
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about self-efficacy related to a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Self-efficacy will be assessed by adopting an 8-item self-efficacy scale for colonoscopy completion in patients with inflammatory bowel diseases and responses will be recorded on a 5-point scale. Higher scores will indicate higher levels of self-efficacy.
Intent to complete a colonoscopy
Time frame: Up to 12 months post-abnormal FIT result
Intervention arm patients will complete a pre- and post-intervention survey that will include questions about intent to complete a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Intent will be measured using a single validated question on a nominal scale with 5 options. Responses will be dichotomized to affirmative intent (definitely will do, will do) or uncertain intent (don't know, will not do, and definitely will not do).
1 secondary outcome
Incidence of completed colonoscopies
Time frame: At 6 months post randomization
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 30 May 2024.
- 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 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 Media Intervention, Best Practice and Questionnaire Administration 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 5 inclusion and 4 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 30 May 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?
Feasibility as measured by study accrual (time frame: Up to 12 months post-abnormal fecal immunochemical test (FIT) result). The study lists 8 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 30 May 2024.