Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid

Not Applicable

Recruiting

• Conditions: Cholangiocarcinoma; Colorectal Cancer; Multiple Myeloma

• Registration Number: NCT06910670
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-30
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in self-efficacy about genomic test results	Baseline, after viewing assigned materials (day 1), and 3-months after enrollment	7-item, Likert scale. This scale has 5 points ranging from strongly disagree to strongly agree. 1= Strongly disagree, 2= Disagree, 3= Neither Agree nor Disagree, 4= Agree, 5= Strongly Agree. All items are scored such that 'strongly agree' reflects a correct response and 'agree' reflects a less confident correct response in the correct direction. This will be scored by adding up the numbers for each of the 7 items regarding self-efficacy. The total score ranges from 7 to 35. A higher score for the participant represents higher participant self-efficacy.

Secondary Outcome Measures

Name	Time	Method
Decisional conflict scores categorized by genomic sequencing testing attitudes	After viewing assigned materials (day 1) and 3-months after enrollment	Genomic sequencing testing attitudes is measured at baseline. 6-items. This scale has 4 points ranging from 'strongly disagree' to 'strongly agree'. 1= Strongly disagree, 4=Strongly agree. This is scored by adding up the numbers for each of the 6 items. The score ranges from 6 to 24. A higher score indicates a higher participant level of trust in genomic research participation.
Change in decisional conflict	After viewing assigned materials (day 1) and 3-months after enrollment	17-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree. All items are scored such that 'strongly disagree' reflects an incorrect response and 'disagree' reflects a less confident incorrect response in the incorrect direction. This will be scored by adding up the numbers for each of the 17 items regarding decisional conflict. The total score ranges from 17 to 85. The higher score for the participant represents higher participant decisional conflict.
Change in knowledge of clinical genetic testing	After viewing assigned materials (day 1) and 3-months after enrollment	12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge.
Change in expectations for potential benefits of cancer genomic sequencing	After viewing assigned materials (day 1) and 3-months after enrollment	Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1= Extremely unlikely, 2= Unlikely, 3= Likely, 4= Extremely likely. This will be scored by adding up the numbers for each of the 6 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations.
Decisional conflict scores categorized by demographic factors	After viewing assigned materials (day 1) and 3-months after enrollment	17-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree. All items are scored such that 'strongly disagree' reflects an incorrect response and 'disagree' reflects a less confident incorrect response in the incorrect direction. This will be scored by adding up the numbers for each of the 17 items regarding decisional conflict. The total score ranges from 17 to 85. The higher score for the participant represents higher participant decisional conflict.; Demographic factors include age, race, SES, and geographic residence.
Knowledge scores categorized by demographic factors	After viewing assigned materials (day 1) and 3-months after enrollment	12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge.; Demographic factors include age, race, SES, and geographic residence.
Decisional conflict scores categorized by genomic literacy	After viewing assigned materials (day 1) and 3-months after enrollment	Genomic literacy will be measured at baseline. 14 items. For 7 items participants will rate their familiarity with genetic terminology on a 7 point scale ranging from strongly disagree to strongly agree. 1= Strongly disagree, 7= Strongly agree. This portion ill be scored by adding up the numbers for each of these 7 items. The total score on this portion ranges from 7 to 49. An additional 7 questions ask participants to fill in a missing word in a statement about genetics. These 7 items are multiple-choice questions and are scored by adding up the number of correct answers. The score on this portion ranges from 0 to 7.
Knowledge scores categorized by genomic literacy	After viewing assigned materials (day 1) and 3-months after enrollment	Genomic literacy will be measured at baseline. 14 items. For 7 items participants will rate their familiarity with genetic terminology on a 7 point scale ranging from strongly disagree to strongly agree. 1= Strongly disagree, 7= Strongly agree. This portion ill be scored by adding up the numbers for each of these 7 items. The total score on this portion ranges from 7 to 49. An additional 7 questions ask participants to fill in a missing word in a statement about genetics. These 7 items are multiple-choice questions and are scored by adding up the number of correct answers. The score on this portion ranges from 0 to 7.
Knowledge scores categorized by genomic sequencing testing attitudes	After viewing assigned materials (day 1) and 3-months after enrollment	Genomic sequencing testing attitudes is measured at baseline. 6-items. This scale has 4 points ranging from 'strongly disagree' to 'strongly agree'. 1= Strongly disagree, 4=Strongly agree. This is scored by adding up the numbers for each of the 6 items. The score ranges from 6 to 24. A higher score indicates a higher participant level of trust in genomic research participation.
Decisional conflict scores categorized by clinical characteristics	After viewing assigned materials (day 1) and 3-months after enrollment	7-item, Likert scale. This scale has 5 points ranging from strongly disagree to strongly agree. 1= Strongly disagree, 2= Disagree, 3= Neither Agree nor Disagree, 4= Agree, 5= Strongly Agree. All items are scored such that 'strongly agree' reflects a correct response and 'agree' reflects a less confident correct response in the correct direction. This will be scored by adding up the numbers for each of the 7 items regarding self-efficacy. The total score ranges from 7 to 35. A higher score for the participant represents higher participant self-efficacy.; Clinical characteristics include cancer type, stage at diagnosis, and primary treatment.
Knowledge scores categorized by clinical characteristics	After viewing assigned materials (day 1) and 3-months after enrollment	12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge.; Clinical characteristics include cancer type, stage at diagnosis, and primary treatment.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States