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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340646
• Other study ID #: 202106129
• Secondary ID: U2CCA252981
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Graham Colditz, M.D., DrPH, MPH
• Phone: 314-454-7939
• Email: colditzg[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 990
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Colon Cancer
• Multiple Myeloma
• Rectal Cancer

Intervention

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.
• Return of Genetic Results: Inherited mutations related to cancer
Participants will receive a novel return of results report that is tailored to their choices.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

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