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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05223 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10950 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm 2 (usual care) | Active Comparator | Patients receive usual care and do not watch the educational video. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Media Intervention | Other | Watch an educational video |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Issaka, MD, MAS | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | May 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Best Practice |
| Other |
Receive usual care |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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. | 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. | 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). | Up to 12 months post-abnormal FIT result |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |