CholangiocarcinomaNCT06910670
Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid
A study testing Standard developed materials and Genetics Advisor Decision Aid in people with Cholangiocarcinoma and Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Colorectal Cancer, Multiple Myeloma
- What is being tested?
- Standard developed materials and Genetics Advisor Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria:
- Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:
- Diagnosis of cholangiocarcinoma
- Diagnosis of multiple myeloma, must be African American
- Diagnosis of colorectal cancer, must be African American and age 65 or older at time of diagnosis
- At least 18 years old.
- Able to understand an IRB-approved informed consent document and agree to participation
- Have access to a personal computer, tablet or mobile device
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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).
- Conditions
- Cholangiocarcinoma, Colorectal Cancer, Multiple Myeloma
- Being tested
- Standard developed materials, Genetics Advisor Decision Aid
- Keywords
- Genetic testing, Decision aid, Participant engagement
- Medical subject headings
- Cholangiocarcinoma, Colorectal Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard developed materialsOther
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
Genetics Advisor Decision AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Genetics Advisor Online Tool | Experimental | The Intervention group will receive the expanded Genetics Advisor decision aid. Receives: Other: Genetics Advisor Decision Aid |
| Control: Standard developed materials | Active comparator | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After viewing assigned materials (day 1) and 3-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start3 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erin Linnenbringer, Ph.D., MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910670
- Sponsor's protocol ID
- 202409214
- Other IDs
- U2CCA252981
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid
- ClinicalTrials.gov ID
- NCT06910670
- Acronym / sponsor ID
- 202409214
- Conditions
- Cholangiocarcinoma, Colorectal Cancer, Multiple Myeloma
- Keywords
- Genetic testing, Decision aid, Participant engagement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 4 Apr 2025 (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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Genetics Advisor Online Tool | Experimental | Other: Genetics Advisor Decision AidThe Intervention group will receive the expanded Genetics Advisor decision aid. |
| Control: Standard developed materials | Active comparator | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard developed materialsParticipants 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 | Other | – |
| Genetics Advisor Decision AidParticipants 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. | Other | Intervention: Genetics Advisor Online Tool |
Primary outcome
Change in self-efficacy about genomic test results
Time frame: 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.
11 secondary outcomes
Change in decisional conflict
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Change in knowledge of clinical genetic testing
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Change in expectations for potential benefits of cancer genomic sequencing
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by demographic factors
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by demographic factors
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by genomic literacy
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by genomic literacy
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by genomic sequencing testing attitudes
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by genomic sequencing testing attitudes
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Decisional conflict scores categorized by clinical characteristics
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Knowledge scores categorized by clinical characteristics
Time frame: After viewing assigned materials (day 1) and 3-months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Erin Linnenbringer, Ph.D., MS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard developed materials and Genetics Advisor Decision Aid in people with Cholangiocarcinoma and Colorectal Cancer, run by Washington University School of Medicine 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?
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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in self-efficacy about genomic test results (time frame: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment). 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 25 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.