Helping patients communicate with oncologists when cancer treatment resistance occurs: a sequential collaborative mixed-method study (HECTOR) to develop, test and implement a patient communication aid. (Preprint)

BACKGROUND Most cancer deaths result from disseminated disease that develops resistance to anti-cancer treatments. Inappropriate communication in this challenging situation may result in unmet patients’ information and support needs. Patient communication aids such as Question Prompt Lists (QPLs) may help. OBJECTIVE This study develops, tests and implements in France, a specific QPL in two contrasted clinical contexts after cancer resistance has developed: 1) the triple negative and luminal B metastatic breast cancer (MBC) and 2) metastatic uveal melanoma (MUM). METHODS A sequential study design, mixed-method collaborative approach is applied. The first step aims to build a specific QPL. Step 1a explores oncologist-patient communication issues, from oncology professionals’ interviews (n~30). Step 1b appraises information and support needs as experienced by patients affected with MBC or MUM, both quantitatively (n=80) and qualitatively (n~20). These data are used to further develop and adapt a QPL for advanced cancer patients, selected from a literature review. We expect to obtain a core QPL comprising questions and concerns commonly expressed by patients affected with a resistant cancer, complemented by specific issues for either MBC or MUM cancer sites. In step 1c, focus groups (n=2) of ‘expert’ cancer patients (n=3), oncologists (n=3) and supportive care specialists (n=3) are conducted to revise the content of a preliminary QPL and to elaborate an acceptable and feasible clinical implementation, potentially facilitated by a coaching intervention. In Step 1d, the content of the QPL V.1 and implementation guidance are validated in a national Delphi process. Step 2 tests the QPL V.1 in real practice with MBC and MUM patients (n=80). Clinical utility is assessed in a pre- versus post-test design, comparing responses to questionnaires administered in step 1b and step 2. RESULTS This study received grants in March and December 2019 and was approved by the French national ethics committee in July 2019. As of December 2020, 28 interviews with oncology professionals have been conducted and are being analyzed. CONCLUSIONS A clinically and culturally tailored QPL is expected to facilitate patients’ participation in consultations, to improve oncologists’ response to their information and support needs, and so foster patients’ psychological adjustment to the diagnosis and follow-up of cancer resistance to treatment. CLINICALTRIAL NCT04118062