ABSTRACT
BACKGROUND: Most cancer-related deaths result from disseminated diseases that develop resistance to anticancer treatments. Inappropriate communication in this challenging situation may result in unmet patient information and support needs. Patient communication aids such as question prompt lists (QPLs) may help. OBJECTIVE: This study aims to develop and pilot-test a specific QPL in the following two contrasting clinical contexts in France after cancer resistance has developed: triple-negative and luminal B metastatic breast cancer (MBC) and metastatic uveal melanoma (MUM). METHODS: A sequential study design with a mixed methods collaborative approach will be applied. The first step aims to build a specific QPL. Step 1a will explore oncologist-patient communication issues from oncology professionals' interviews (n=20 approximately). Step 1b will appraise information and support needs experienced by patients with MBC or MUM both quantitatively (n=80) and qualitatively (n=40 approximately). These data will be used to develop and pilot-test a QPL specific to patients with cancer experiencing initial or acquired resistance to treatment. We expect to obtain a core QPL that comprises questions and concerns commonly expressed by patients with resistant cancer and is complemented by specific issues for either MBC or MUM cancer sites. In step 1c, 2 focus groups of patients with any type of metastatic cancer (n=4) and health care professionals (n=4) will be conducted to revise the content of a preliminary QPL and elaborate an acceptable and feasible clinical implementation. In step 1d, the content of the QPL version 1 and implementation guidance will be validated using a Delphi process. Step 2 will pilot-test the QPL version 1 in real practice with patients with MBC or MUM (n=80). Clinical utility will be assessed by comparing responses to questionnaires administered in step 1b (QPL-naive historical control group) and step 2 (QPL intervention group). RESULTS: This study received grants in March and December 2019 and was approved by the French national ethics committee in July 2019. As of October 2021, interviews with oncology professionals have been conducted and analyzed (N=26 to reach saturation), and 39 and 27 patients with MBC and MUM, respectively, have been recruited. CONCLUSIONS: A clinically and culturally tailored QPL is expected to facilitate patients' participation in consultations, improve oncologists' responses to patients' information and support needs, and thus foster patients' psychological adjustment to the diagnosis and follow-up of cancer resistance to treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04118062; http://clinicaltrials.gov/ct2/show/NCT04118062. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26414.
ABSTRACT
PURPOSE: Many institutions throughout the world have launched precision medicine initiatives in oncology, and a large amount of clinical and genomic data is being produced. Although there have been attempts at data sharing with the community, initiatives are still limited. In this context, a French task force composed of Integrated Cancer Research Sites (SIRICs), comprehensive cancer centers from the Unicancer network (one of Europe's largest cancer research organization), and university hospitals launched an initiative to improve and accelerate retrospective and prospective clinical and genomic data sharing in oncology. MATERIALS AND METHODS: For 5 years, the OSIRIS group has worked on structuring data and identifying technical solutions for collecting and sharing them. The group used a multidisciplinary approach that included weekly scientific and technical meetings over several months to foster a national consensus on a minimal data set. RESULTS: The resulting OSIRIS set and event-based data model, which is able to capture the disease course, was built with 67 clinical and 65 omics items. The group made it compatible with the HL7 Fast Healthcare Interoperability Resources (FHIR) format to maximize interoperability. The OSIRIS set was reviewed, approved by a National Plan Strategic Committee, and freely released to the community. A proof-of-concept study was carried out to put the OSIRIS set and Common Data Model into practice using a cohort of 300 patients. CONCLUSION: Using a national and bottom-up approach, the OSIRIS group has defined a model including a minimal set of clinical and genomic data that can be used to accelerate data sharing produced in oncology. The model relies on clear and formally defined terminologies and, as such, may also benefit the larger international community.