Cholangiocarcinoma, Colon Cancer, Multiple Myeloma, Rectal Cancer
Conditions
Keywords
Participant engagement, Genetic testing, Cholangiocarcinoma, Multiple Myeloma, Colorectal cancer, Underrepresented populations
Brief 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.
Interventions
OTHERReturn of Genetic Results: Biomarker information from cancer cells
Participants will receive a novel return of results report that is tailored to their choices.
OTHERReturn of Genetic Results: Inherited mutations related to cancer
Participants will receive a novel return of results report that is tailored to their choices.
OTHERReturn 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.
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
The Foundation for Barnes-Jewish Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 65 years old at the time of diagnosis. * At least 18 years old * Able to understand and willing to sign an IRB-approved written informed consent document
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant knowledge of clinical genetic testing | Through completion of follow-up (estimated to be 5 years) | 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. |
| Participant expectations of benefit | Through completion of follow-up (estimated to be 5 years) | 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. |
| Participant personal utility | Through completion of follow-up (estimated to be 5 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant anxiety | Through completion of follow-up (estimated to be 5 years) | 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. |
| Participant satisfaction | Through completion of follow-up (estimated to be 5 years) | 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. |
Countries
United States
Contacts
CONTACTGraham Colditz, M.D., DrPH, MPH
CONTACTBettina Drake, Ph.D., MPH
PRINCIPAL_INVESTIGATORGraham Colditz, M.D., DrPH, MPH
Washington University School of Medicine
Outcome results
None listed