NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.
Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).
Regular nephrology healthcare provided at a NEPTUNE study site.
Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match
None
Single group
Communication
Other interventionThe NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient \[adult and pediatric\] communication, and health education.
Matched participants with at least one clinical trial receive a MNB assessment
Proportion of NEPTUNE Match participants with at least one matching clinical trial, defined as receiving a Molecular Nephrology Board (MNB) assessment that provides a match to at least one targeted therapy in an ongoing clinical trial
Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score
Key findings from MNB trial matching analyses and deliberations will be conveyed to study participants using a NEPTUNE Match Report that summarizes the findings. The report indicates the strength of matching to ongoing clinical trials and the uncertainty and research origins of the information. A sample Match Report can be found in Appendix C. The report will not contain individual data elements reviewed by the MNB. The creation of NEPTUNE Match Reports will follow health education principles including matching of content to patients' informational needs and health literacy levels, use of visual aids to clarify meaning of information, and avoidance of information overload of the participant.
Kidney health endpoints that are specific to each individual trial
The analytic integration supporting the Molecular Nephrology Board (MNB) case review will be initiated and will occur. The MNB will conduct the discussion and generate the integrated data summary and case report inclusive of clinical trial matching by webinar. Input from the MNB will be used to generate a final version of the participant NEPTUNE Match Report. This is a longitudinal outcome that will be assessed at the end of the study relative to endpoints specific to matched clinical trials, assessing the superiority of stratification (matching or alignment of patient molecular profiles to targeted therapies in clinical trials) to non-stratification.
Efficacy of communication methods at follow up, measured by Teach Back of key concepts
3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching.
Psychological distress measured by the STAI assessment
State Trait Anxiety Inventory (mini-STAI) scale will be used to assess a participant's psychological distress around their participation in NEPTUNE Match at the consent visit and the follow up visit.
Psychological distress measured by the FACToR-NEPTUNE assessment
FACToR-NEPTUNE is a measure that has been modified from the Feelings About genomiC Testing Results (FACToR). FACToR-12 is used to assess the psychosocial impact of returning genomic findings to patients in research and clinical practice. In the FACToR-NEPTUNE assessment the measure will assess the psychosocial impact after receiving the NEPTUNE Match Report.
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
