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.

Conditions

• Cholangiocarcinoma
• Multiple Myeloma
• Colon Cancer
• Rectal 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

Primary Outcome Measures

• 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.

Countries

United States

Locations and Investigators

• Washington University School of Medicine, St Louis, United States (Recruiting)
  • Graham Colditz, M.D., DrPH, MPH
  • Bettina Drake, Ph.D., MPH
  • Graham Colditz, M.D., DrPH, MPH (Principal Investigator)
  • Li Ding, Ph.D.
  • Bettina Drake, Ph.D.
  • Ryan Fields, M.D.
  • Yin Cao, ScD, MPH
  • Feng Chen, Ph.D.
  • Patricia Dickson, M.D.
  • Eric Duncavage, M.D.
  • Mark Fiala, MSW
  • Aimee James, Ph.D., MPH
  • Reyka Jayasinge, Ph.D.
  • Kian-Huat Lim, M.D., Ph.D.
  • Erin Linnenbringer, Ph.D., MS
  • Jessica Mozersky, Ph.D.
  • Mary Politi, Ph.D.
  • David Spencer, M.D., Ph.D.
  • Tunji Toriola, M.D., Ph.D., MPH
  • Ravi Vij, M.D., MBA
  • Mark Watson, M.D., Ph.D.
  • Fei Wan, Ph.D.
  • Mike Wendl, DSC, MS, PHS
  • Matthew Wyczalkowski, Ph.D.
  • Stephanie Solomon Cargill, Ph.D., MSPH

Study Officials

• Graham Colditz, M.D., DrPH, MPH (Principal Investigator) — Washington University School of Medicine