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OpenTrials
Active, not recruiting

NCT Number: NCT06910670

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

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Blood Protein Disorders Carcinoma Cardiovascular Diseases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Paraproteinemias Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard developed materials

Other

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 Aid

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in decisional conflict

    Time frame: 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.

  2. Change in knowledge of clinical genetic testing

    Time frame: 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.

  3. Change in expectations for potential benefits of cancer genomic sequencing

    Time frame: 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.

  4. Decisional conflict scores categorized by demographic factors

    Time frame: 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.

  5. Knowledge scores categorized by demographic factors

    Time frame: 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.

  6. Decisional conflict scores categorized by genomic literacy

    Time frame: 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.

  7. Knowledge scores categorized by genomic literacy

    Time frame: 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.

  8. Decisional conflict scores categorized by genomic sequencing testing attitudes

    Time frame: 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.

  9. Knowledge scores categorized by genomic sequencing testing attitudes

    Time frame: 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.

  10. Decisional conflict scores categorized by clinical characteristics

    Time frame: 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.

  11. Knowledge scores categorized by clinical characteristics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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