Genetic Results Return for Cancer Patients

Recruiting at 1 trial location

Overseen By Bettina Drake, Ph.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-African-American, Over 65, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

990 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the impact of sharing genetic information on cancer patients and survivors, focusing on their health and satisfaction. Participants will undergo genetic testing and can choose which results to receive, such as information about cancer-related mutations or other health issues. The trial aims to understand how these choices affect participants' knowledge and decision-making. The study includes a component called Participant Engagement and Genomic Result Return, which examines how patients interact with and understand their genetic information. It is suitable for individuals diagnosed with cholangiocarcinoma, African-American patients with multiple myeloma, or African-American patients diagnosed with colon or rectal cancer before age 65. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of genetic information on patient decision-making and satisfaction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for cancer patients?

Research has shown that sharing genetic results with participants is generally safe. Although specific safety data for this practice is lacking, past studies provide some guidance. Experts have developed ethical guidelines to help researchers share genetic information safely, ensuring participants understand the information and can choose which results they wish to receive.

The process of sharing genetic results focuses on communication. Participants can select the genetic information they want to know, such as mutations related to cancer or other health issues. This approach aims to help participants make informed decisions for themselves.

In summary, while specific safety data remains limited, the process is carefully planned and communicated to ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how returning genetic results to cancer patients might impact their care and decision-making. Unlike traditional cancer treatments that focus on chemotherapy, radiation, or surgery, this approach involves sharing detailed genetic information with patients, which could empower them with insights into their cancer's biology. This could lead to more personalized treatment plans and allow patients to make informed choices about their health. The trial aims to uncover whether receiving such information influences patient outcomes and satisfaction, potentially paving the way for integrating genomic data into standard cancer care practices.

What evidence suggests that this trial's approach to returning genomic results could be effective for cancer patients?

Research has shown that sharing genomic sequencing results can enhance communication between patients and their doctors. In this trial, participants can receive their genetic results, potentially leading to better health outcomes and greater personal satisfaction. Studies have found that receiving genetic results often makes patients feel more informed and less uncertain about their healthcare choices. Additionally, awareness of inherited mutations can help patients make proactive health decisions. Researchers are refining this process to ensure participants gain the most benefit from the information. ^{2 6 7 8 9}

Who Is on the Research Team?

Graham Colditz, M.D., DrPH

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for cancer patients or survivors with conditions like Multiple Myeloma, Colorectal Cancer, Bile Duct Cancer, and Colon Cancer. They will be involved in research by choosing what genetic results they want to receive about inherited mutations and biomarkers from their cancer cells.

Inclusion Criteria

I am African-American, under 50, and diagnosed with colon or rectal cancer.

Able to understand and willing to sign an IRB-approved written informed consent document

I am African-American with multiple myeloma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genomic Sequencing and Decision-Making

Participants undergo germline genomic sequencing and decide on the types of genomic results they wish to receive

6-8 weeks

1 visit (in-person) for sequencing, multiple discussions (virtual or in-person) for decision-making

Follow-up

Participants are monitored for expectations of benefit, personal utility, knowledge, anxiety, and satisfaction after receiving genomic results

1 year

Assessments at 6-8 weeks and 1 year after results disclosure

What Are the Treatments Tested in This Trial?

Interventions

• Participant Engagement and Genomic Result Return

Trial Overview The study tests the effect of giving patients a choice in receiving their own genomic information. It looks at how this choice impacts their knowledge, expectations of benefit, personal utility, and decision-making process regarding health.

How Is the Trial Designed?

Group I: Return of Genetic Results Experimental Treatment 3 Interventions

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

Group II: No Return of Genetic Results Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A national survey revealed that 78.5% of research participants value receiving their results, and 70.3% believe it would increase their trust in researchers, highlighting the importance of transparency in research.

Participants particularly valued results related to genetic effects on medication response and disease risk prediction, indicating a need for policies that accommodate diverse informational needs based on factors like education, race/ethnicity, and age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding What Information Is Valued By Research Participants, And Why. Wilkins, CH., Mapes, BM., Jerome, RN., et al.[2021]

Parents of children enrolled in genomic biobank research reported higher satisfaction when given the option to set specific preferences for receiving individual research results (IRRs), particularly in the 'Granular' group that used a preference-setting tool.

The study, which surveyed 2,718 parents out of 11,391 contacted, found that those who opted not to receive any IRRs were the least satisfied, suggesting that allowing participants to choose their level of engagement may enhance biobank participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant Satisfaction With a Preference-Setting Tool for the Return of Individual Research Results in Pediatric Genomic Research. Holm, IA., Iles, BR., Ziniel, SI., et al.[2020]

Participants in a study of 54 biobank contributors expressed significant interest in unexpected pharmacogenomic results related to the cancer drug 5-fluorouracil, indicating a strong desire for clear communication about these findings and their implications for health.

The study revealed that participants had questions about how to share these results with healthcare providers and family, highlighting the need for effective messaging that considers their health identity and the practicalities of conveying this information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating unexpected pharmacogenomic results to biobank contributors: A focus group study. Meagher, KM., Curtis, SH., Borucki, S., et al.[2021]

A survey conducted in Eastern Canada revealed that people are very interested in receiving unexpected genomic findings related to treatable disorders and carrier results, but less so for non-treatable disorders and unclassified variants.

Factors such as a desire for control over genomic data and a history of genetic conditions significantly increased interest in receiving unexpected findings, while concerns about genomic sequencing decreased interest in all unexpected results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public interest in unexpected genomic findings: a survey study identifying aspects of sequencing attitudes that influence preferences. Etchegary, H., Pullman, D., Simmonds, C., et al.[2022]

A study involving 49 participants in genomics research highlighted that mistrust is a significant barrier to engagement, yet individuals are willing to participate to share their views and benefit their communities.

Participants prioritized the return of results for life-threatening conditions as the most important, emphasizing the need for engagement strategies that allow detailed sharing of perspectives to improve trust and policy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement and return of results preferences among a primarily African American genomic sequencing research cohort. Lewis, KL., Turbitt, E., Chan, PA., et al.[2022]

A systematic review of 221 studies involving 118,874 stakeholders revealed a strong interest among genomic research participants in receiving individual research results (IRR), with a particular emphasis on results that could impact clinical management.

Researchers and health professionals generally support returning IRR, especially when the results are reliable and clinically relevant, and evidence suggests that returning actionable results does not cause significant psychological harm to participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return of individual research results from genomic research: A systematic review of stakeholder perspectives. Vears, DF., Minion, JT., Roberts, SJ., et al.[2021]

In a study involving 39 cancer genetics participants, 70% chose to receive their CDKN2A gene test results, and those who did reported no negative psychological effects or changes in melanoma prevention behaviors after disclosure.

While the process of disclosing results was time-consuming and costly for researchers, 59% of participants indicated that receiving their results made them more likely to participate in future research, highlighting a potential benefit of individual result disclosure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disclosing individual CDKN2A research results to melanoma survivors: interest, impact, and demands on researchers. Christensen, KD., Roberts, JS., Shalowitz, DI., et al.[2021]

Patients receiving results of variants of uncertain significance (VUS) who were referred to genetic counseling reported better understanding and less confusion compared to those who were not referred, highlighting the importance of expert guidance in the return of results process.

Despite VUS not directly impacting healthcare decisions, patients expressed a desire for clearer communication and ongoing support, suggesting that improving the return of results process with patient-friendly resources could enhance their overall experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation matters: How patient experiences differ when genetic counseling accompanies the return of genetic variants of uncertain significance. Patel, HV., Henrikson, NB., Ralston, JD., et al.[2022]

In a study involving 501 primary care providers, cash card incentives requiring email activation resulted in lower survey response rates (41.9%) compared to checks (54.1%), indicating that checks may be a more effective incentive for clinician surveys.

The effectiveness of checks as an incentive varied by geographic location, showing a significant positive impact on response rates specifically in Los Angeles and Philadelphia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of up-front cash cards and checks as incentives for participation in a clinician survey: a study within a trial. Pace, LE., Lee, YS., Tung, N., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025001303

Optimizing participant and community engagement in ... Return of genomic sequencing results emerged as a key area for optimization, with centers working to improve communication effectiveness and participant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6797333/

Health outcomes, utility and costs of returning incidental ... We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06340646?cond=rectum+cancer&aggFilters=status%3A

Washington University Participant Engagement and ... Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely ...

4. nature.com nature.com/articles/s41431-022-01069-y

Preferences for return of germline genome sequencing ... The aim of this study was to discern preferences for return of results by cancer patients who have actually undergone GS.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9889863/

Promoting patient engagement in cancer genomics research ... In support of engagement as an ongoing process, we identified that patient engagement in cancer genomics research entails interactions between participants and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4617203/

Returning a Research Participant's Genomic Results to ... In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this ...

7. mrctcenter.org mrctcenter.org/resource/returning-of-individual-research-results-and-data-digging-deeper-into-genetic-results-and-secondary-findings/

Digging Deeper into Genetic Results and Secondary Findings The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent ...

8. withpower.com withpower.com/trial/phase-multiple-myeloma-9-2022-b80dd

Genetic Results Return for Cancer Patients Is the return of genetic results safe for participants? The research does not provide specific safety data about the return of genetic results, but it ...

9. nature.com nature.com/articles/s41431-023-01328-6

A practical checklist for return of results from genomic ... The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants.