Brédart Anne, Rault Aude, Terrasson Johanna, Seigneur Etienne, De Koning Leanne, Hess Elisabeth, Savignoni Alexia, Cottu Paul, Pierga Jean-Yves, Piperno-Neumann Sophie, Rodrigues Manuel, Bouleuc Carole, Dolbeault Sylvie
Psycho-Oncology Unit, Institut Curie, Paris Sciences et Lettres Research University, Paris, France.
Psychopathology and Health Process, Paris University, Boulogne Billancourt, France.
JMIR Res Protoc. 2022 Jan 12;11(1):e26414. doi: 10.2196/26414.
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.
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).
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).
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.
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.
ClinicalTrials.gov NCT04118062; http://clinicaltrials.gov/ct2/show/NCT04118062.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26414.
大多数癌症相关死亡是由对抗癌治疗产生耐药性的播散性疾病导致的。在这种具有挑战性的情况下，沟通不当可能导致患者的信息需求和支持需求无法得到满足。诸如问题提示列表（QPLs）之类的患者沟通辅助工具可能会有所帮助。
本研究旨在针对法国癌症出现耐药后的以下两种截然不同的临床情况开发并进行预试验一种特定的QPL：三阴性和管腔B型转移性乳腺癌（MBC）以及转移性葡萄膜黑色素瘤（MUM）。
将采用顺序研究设计和混合方法协作方法。第一步旨在构建一个特定的QPL。步骤1a将通过肿瘤学专业人员访谈（约n = 20）探索肿瘤医生与患者的沟通问题。步骤1b将定量（n = 80）和定性（约n = 40）评估MBC或MUM患者所经历的信息需求和支持需求。这些数据将用于开发并预试验一种针对对治疗产生初始或获得性耐药的癌症患者的特定QPL。我们期望获得一个核心QPL，其中包含耐药癌症患者普遍表达的问题和担忧，并辅以针对MBC或MUM癌灶的特定问题。在步骤1c中，将针对任何类型转移性癌症患者（n = 4）和医疗保健专业人员（n = 4）进行2个焦点小组讨论，以修订初步QPL的内容并制定可接受且可行的临床实施方案。在步骤1d中，将使用德尔菲法验证QPL版本1的内容和实施指南。步骤2将在MBC或MUM患者（n = 80）的实际临床实践中对QPL版本1进行预试验。通过比较步骤1b（未使用QPL的历史对照组）和步骤2（QPL干预组）中问卷调查的回答来评估临床效用。
本研究于2019年3月和12月获得资助，并于2019年7月获得法国国家伦理委员会批准。截至2021年10月，已对肿瘤学专业人员进行了访谈并分析（N = 26达到饱和），分别招募了39例MBC患者和27例MUM患者。
预计一种根据临床和文化定制的QPL将促进患者参与会诊，改善肿瘤医生对患者信息需求和支持需求的回应，从而促进患者对癌症耐药诊断和后续治疗的心理调适。
ClinicalTrials.gov NCT04118062；http://clinicaltrials.gov/ct2/show/NCT04118062。
国际注册报告识别码（IRRID）：DERR1-10.2196/26414。
