Genetic Results Return for Cancer Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Disqualifiers: Non-African-American, Over 65, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Participant Engagement and Genomic Result Return for cancer patients?
Research shows that when genetic counseling is included in the return of genetic results, patients feel less confused and more confident in understanding their results. Additionally, most people value receiving research results, which can increase their trust in researchers.
12345Is the return of genetic results safe for participants?
The research does not provide specific safety data about the return of genetic results, but it highlights the importance of effective communication and engagement strategies to improve participant understanding and trust.
12367How does this treatment differ from other treatments for cancer patients?
This treatment is unique because it focuses on returning genetic results to cancer patients, which can provide valuable insights into how their genetics affect medication response and disease risk. Unlike standard treatments that may not include this personalized genetic information, this approach aims to enhance patient engagement and trust by offering detailed genetic insights that can inform treatment decisions.
23489Eligibility Criteria
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 18 years old or older.
+2 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Return of Genetic ResultsExperimental Treatment3 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 ResultsActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
The Foundation for Barnes-Jewish HospitalCollaborator
National Cancer Institute (NCI)Collaborator
References
Implementation matters: How patient experiences differ when genetic counseling accompanies the return of genetic variants of uncertain significance. [2022]Precision medicine presents challenges for effective return of results (ROR) to patients, particularly for variants of uncertain significance (VUS) where the need for genetic counseling and the impact of results are underexplored. We investigated patients' experiences with VUS ROR. Through interviews we compared experiences of patients who were referred to genetic counseling with those not referred. Although participants from both groups (n=16) reported curious enthusiasm and relief after ROR, the 5 referred participants reported less confusion, less disappointment, and better confidence in understanding their results than the 11 non-referred participants. Although VUS did not impact healthcare or daily lives, some participants who shared VUS fostered communication about future healthcare. Suggested ROR improvements included patient-friendly terminology, on-demand education, and ongoing consultation. Although patient experience of VUS improved when ROR involved expert consultation, scarcity of genetic counselors presents challenges. Improving the ROR process with patient-centered solutions could enhance the patient experience of receiving VUS.
Understanding What Information Is Valued By Research Participants, And Why. [2021]There is growing public demand that research participants receive all of their results, regardless of whether clinical action is indicated. Instead of the standard practice of returning only actionable results, we propose a reconceptualization called "return of value" to encompass the varied ways in which research participants value specific results and more general information they receive beyond actionable results. Our proposal is supported by a national survey of a diverse sample, which found that receiving research results would be valuable to most (78.5 percent) and would make them more likely to trust researchers (70.3 percent). Respondents highly valued results revealing genetic effects on medication response and predicting disease risk, as well as information about nearby clinical trials and updates on how their data were used. The information most valued varied by education, race/ethnicity, and age. Policies are needed to enable return of information in ways that recognize participants' differing informational needs and values.
Engagement and return of results preferences among a primarily African American genomic sequencing research cohort. [2022]Genomics researchers are increasingly interested in what constitutes effective engagement of individuals from underrepresented groups. This is critical for longitudinal projects needed to inform the implementation of precision medicine. Return of results is one opportunity for engagement. The aims of this study were to determine participant perspectives on optimal engagement strategies and priorities for return of results and the extent to which focus groups were an effective modality for gathering input on these topics. We conducted six professionally moderated focus groups with 49 participants in a genomics research study. Transcripts from audio-recorded sessions were coded by two researchers and themes were discussed with the wider research team. All groups raised the issue of mistrust. Individuals participated nonetheless to contribute their perspectives and benefit their community. Many group members preferred engagement modalities that are offered to all participants and allow them to share the nuances of their perspectives over the use of participant representatives and surveys. All groups created a consensus ranking for result return priorities. Results for life-threatening conditions were the highest priority to return, followed by those related to treatable conditions that affect physical or mental health. We advocate for engagement strategies that reach as many participants as possible and allow them to share their perspectives in detail. Such strategies are valued by participants, can be effective for developing return of results policies, and may help institutions become more trustworthy.
Disclosing individual CDKN2A research results to melanoma survivors: interest, impact, and demands on researchers. [2021]Whether to return individual research results from cancer genetics studies is widely debated, but little is known about how participants respond to results disclosure or about its time and cost burdens on investigators.
Comparison of up-front cash cards and checks as incentives for participation in a clinician survey: a study within a trial. [2021]Evidence is needed regarding effective incentive strategies to increase clinician survey response rates. Cash cards are increasingly used as survey incentives; they are appealing because of their convenience and because in some cases their value can be reclaimed by investigators if not used. However, their effectiveness in clinician surveys is not known. In this study within the BRCA Founder OutReach (BFOR) study, a clinical trial of population-based BRCA1/2 mutation screening, we compared the use of upfront cash cards requiring email activation versus checks as clinician survey incentives.
Participant Satisfaction With a Preference-Setting Tool for the Return of Individual Research Results in Pediatric Genomic Research. [2020]The perceived benefit of return of individual research results (IRRs) in accordance to participants' preferences in genomic biobank research is unclear. We developed an online preference-setting tool for return of IRRs based on the preventability and severity of a condition, which included an opt-out option for IRRs for mental illness, developmental disorders, childhood-onset degenerative conditions, and adult-onset conditions. Parents of patients
Communicating unexpected pharmacogenomic results to biobank contributors: A focus group study. [2021]The goals of this study were to explore 1) the impact of returning unexpected pharmacogenomic (PGx) results to biobank contributors, and 2) participant views about improving communication.
Public interest in unexpected genomic findings: a survey study identifying aspects of sequencing attitudes that influence preferences. [2022]We describe public preferences for unexpected genomic findings and explore predictors of preferences using an online survey in an Eastern Canadian province. Items measuring attitudes toward features of unexpected findings and genomic sequencing concerns were entered in logistic regression models predicting interest in unexpected findings. Very high levels of interest were observed in unexpected findings for treatable disorders and carrier results, with lesser interest in unexpected findings for non-treatable disorders and unclassified variants. Respondents who endorsed items measuring features of patient control and choice over their genomic data and testing options were 3-5 times more likely to be very interested in receiving unexpected findings. Respondents with high genomic sequencing concerns were less interested in the return of any unexpected result. Self-reported history of a genetic condition was significantly related to interest in receiving most categories of unexpected genomic information, while prior use of direct-to-consumer testing was significantly related only to interest in the return of unexpected genomic findings for disorders not currently treatable. Findings highlight the need for specific elements of information and transparency regarding the return of unexpected findings and can inform the development of patient-centered materials and return of results policies.
Return of individual research results from genomic research: A systematic review of stakeholder perspectives. [2021]Despite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders' perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants.