Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)

The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Rectal Cancer; Cholangiocarcinoma; Colon Cancer
• Intervention / Treatment: Other: Return of Genetic Results: Biomarker information from cancer cells; Other: Return of Genetic Results: Inherited mutations related to cancer; Other: Return of Genetic Results: Inherited mutations related to other medical issues

• Study Type: Interventional
• Enrollment (Estimated): 990
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Graham Colditz, M.D., DrPH, MPH; Phone Number: 314-454-7939; Email: colditzg@wustl.edu
• Study Contact Backup: Name: Bettina Drake, Ph.D., MPH; Phone Number: 314-747-4534; Email: drakeb@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Eric Duncavage, M.D.
      • Sub-Investigator: Kian-Huat Lim, M.D., Ph.D.
      • Sub-Investigator: Fei Wan, Ph.D.
      • Sub-Investigator: Mary Politi, Ph.D.
      • Sub-Investigator: Ryan Fields, M.D.
      • Sub-Investigator: Li Ding, Ph.D.
      • Sub-Investigator: David Spencer, M.D., Ph.D.
      • Sub-Investigator: Mark Watson, M.D., Ph.D.
      • Contact: Graham Colditz, M.D., DrPH, MPH; Phone Number: 314-454-7939; Email: colditzg@wustl.edu
      • Contact: Bettina Drake, Ph.D., MPH; Phone Number: 314-747-4534; Email: drakeb@wustl.edu
      • Principal Investigator: Graham Colditz, M.D., DrPH, MPH
      • Sub-Investigator: Bettina Drake, Ph.D.
      • Sub-Investigator: Yin Cao, ScD, MPH
      • Sub-Investigator: Feng Chen, Ph.D.
      • Sub-Investigator: Kia Davis, ScD, MPH
      • Sub-Investigator: Patricia Dickson, M.D.
      • Sub-Investigator: Mark Fiala, MSW
      • Sub-Investigator: Aimee James, Ph.D., MPH
      • Sub-Investigator: Reyka Jayasinge, Ph.D.
      • Sub-Investigator: Erin Linnenbringer, Ph.D., MS
      • Sub-Investigator: Jessica Mozersky, Ph.D.
      • Sub-Investigator: Tunji Toriola, M.D., Ph.D., MPH
      • Sub-Investigator: Ravi Vij, M.D., MBA
      • Sub-Investigator: Mike Wendl, DSC, MS, PHS
      • Sub-Investigator: Matthew Wyczalkowsi, Ph.D.
      • Sub-Investigator: Stephanie Solomon Cargill, Ph.D., MSPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria:

• Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.

  • If diagnosed with multiple myeloma, must be African-American.
  • If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 50 years old.
  • At least 18 years old
  • Able to understand and willing to sign an IRB-approved written informed consent document

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Return of Genetic Results; Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. 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
Experimental: Return of Genetic Results; Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. 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: Return of Genetic Results: Biomarker information from cancer cells; Participants will receive a novel return of results report that is tailored to their choices.; Other: Return of Genetic Results: Inherited mutations related to cancer; Participants will receive a novel return of results report that is tailored to their choices.; Other: Return of Genetic Results: Inherited mutations related to other medical issues; Participants will receive a novel return of results report that is tailored to their choices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant knowledge of clinical genetic testing	11-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, 6-11) 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, and 5) are reverse scored so that 'strongly agree' reflects a correct response and 'somewhat agree' reflect 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 5 to 55. A higher score for the participant represents higher participant knowledge.	6-8 weeks after results have been received and one year after disclosure of results
Participant expectations of benefit	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=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree. This will be scored by adding up the numbers for each of the 8 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.	6-8 weeks after results have been received and one year after disclosure of results
Participant personal utility	Participant personal utility will be measured on a 7-point scale ranging from not at all useful to extremely useful. 1=Not at all useful, 2=A little useful, 3=Somewhat useful, 4=Neutral, 5=Useful, 6=Very useful, 7=Extremely useful. This will be scored by adding up the numbers for each of the 14 items regarding participant personal utility. The total score ranges from 14 to 98. A higher score for the participant represents higher personal utility.	6-8 weeks after results have been received and one year after disclosure of results

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant anxiety	Participant anxiety will be measured using a 5-point Likert scale ranging from not at all to very much. 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much. This will be scored by adding up the numbers for each of the 6 items regarding participant cancer worry. The total score ranges from 0 to 24. A higher score for the participant represents higher participant cancer worry.	Baseline, 6-8 weeks after results have been received, and one year after disclosure of results
Participant satisfaction	Satisfaction will be measured using a 5-point Likert scale ranging from extremely satisfied to not at all. 1=Not at all satisfied, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Extremely satisfied. The total score ranges from 1 to 5. A higher score for the participant represents higher participant satisfaction.	Baseline, 6-8 weeks after results have been received, and one year after disclosure of results

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); The Foundation for Barnes-Jewish Hospital
• Investigators: Principal Investigator: Graham Colditz, M.D., DrPH, MPH, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Colorectal cancer; Cholangiocarcinoma; Genetic testing; Participant engagement; Underrepresented populations
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma; Cholangiocarcinoma
• Other Study ID Numbers: 202106129; U2CCA252981 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: The investigators agree to deposit data into database of Genotypes and Phenotypes (dbGaP) repository after data cleaning and quality control as soon as possible but no later than within three months, or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. When data are released from dbGaP, the data will be made available to the Genomic Data Commons (GDC).
• IPD Sharing Access Criteria: The investigators agree that they will identify where the data will be available (dbGaP and GDC) and how to access the data in any publications and presentations that they author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. As they will be using the database of Genotypes and Phenotypes (dbGaP), which is an NIH-funded repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No