An interventional study of Standard developed materials and Genetics Advisor Decision Aid in Cholangiocarcinoma, Colorectal Cancer and Multiple Myeloma, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research
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).
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 197 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility Criteria:
Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:
The Intervention group will receive the expanded Genetics Advisor decision aid.
Other: Genetics Advisor Decision Aid
The control group will receive a description of each type of genomic sequencing result they could receive using the standard informed consent process for the return-of-results protocol.
Participants will be given the option to receive different types of results from genomic sequencing. The choices available to them will be explained by research staff following a script that describes what each type of result means. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
Participants will be given the option to receive different types of results from genomic sequencing. The participants will be given access to a web-based decision aid that elicits participants' values and preferences for receiving results from cancer genomic sequencing to guide them making a decision about what types of results they would like to receive. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues.
Change in self-efficacy about genomic test results
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.
Time frame: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
Change in decisional conflict
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Change in knowledge of clinical genetic testing
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Change in expectations for potential benefits of cancer genomic sequencing
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by demographic factors
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by demographic factors
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by genomic literacy
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by genomic literacy
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by genomic sequencing testing attitudes
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by genomic sequencing testing attitudes
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by clinical characteristics
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by clinical characteristics
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.
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Plan to share: Yes — Will share all data, software and know-how generated during the course of this work, without limitations except as prevented by prior agreement. This will include both the final datasets, as well as the data necessary to complete the aims. Will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Wherever applicable, data will be deposited to appropriate public repositories. All participants whose genomic data are collected will be consented for broad data sharing, and their genomic data will be included in the study deposits. Data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and diagnosis, consistent with applicable laws and regulations.
Supporting information: Study protocol, Sap
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Washington University School of Medicine