跳至主要内容
临床试验/NCT04118062
NCT04118062已完成不适用

Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. A Qualitative Cross-sectional Study of Professionals, Patients, Parents of Sick Children, and Expert Patients, in the Context of Triple Negative or Luminal B Breast Cancer, Metastatic Uveal Melanoma and Pediatric Cancers.

Institut Curie2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Acceptability of the booklet evaluated

研究概览

简要总结

Resistance to treatment is one of the major themes in cancer research. Despite this, the definition and clinical implications of resistance to treatment remain under-explored, and patient-physician communication in this context still constitutes a challenge. When resistance to cancer treatments occurs, physicians not only have to explain to the patient the phenomenon of resistance, often based on complex results (biological results, genomic tests, imaging, etc.), but also need to offer alternative therapies, whilst fostering shared medical decision-making. These different tasks are particularly challenging for clinicians, especially since there are large individual differences at patient level. Indeed, each patient has his or her own unique information needs, capacity for understanding, and level of desire to participate in treatment decisions.

详细描述

Although a challenge, better communicating around resistance to treatment carries many potential benefits. Indeed, in similar contexts of announcement of bad news and choice of care, Parker and collaborators (1) have highlighted the positive impact of individualized care, respecting the needs, quality of care, and quality of life of patients. Given the clinical stake, and the lack of scientific knowledge devoted to communication in the context of resistance to treatment, it appears necessary to better understand its modalities. In this perspective, research has proven the value of tools for supporting communication, including the issue of question booklets for patients. These tools provide patients with a list of questions submitted to them before the medical consultation, and which they can ask during the consultation, and throughout the treatment. This tool fosters communication by helping the patient obtain a level of information that is adapted to his or her needs and experience, and thus, to be better prepared for care. Despite significant interest for these booklets in the field of oncology, none has yet been developed in the specific context of resistance to treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients:
  • To be 18 years of age or older ;
  • To have metastatic uveal melanoma (MUM) or triple negative or luminal B breast cancer ;
  • To have received the information that the disease is resistant to treatment ;
  • To have read the information and signed the informed consent.
  • Parents of a sick child:
  • To be a parent (parental authority holder) of a child with cancer ;
  • To have received the information that the child disease is resistant to treatment ;
  • To have read the information and signed the informed consent.
  • Expert patients:
  • To be 18 years of age or older ;
  • To have had cancer (regardless the cancer site) ;
  • To participated to an expert patient training (fine knowledge of the illness, experience with the disease) ;
  • To have read the information and signed the informed consent.
  • Professionals:
  • To be an oncologist (medical oncologist, surgeon, radiotherapist, supportive care specialist) and/or to be a researcher in oncology (doctor, biologist, geneticist ...) ;
  • To have patients with a triple-negative or luminal B breast cancer or metastatic uveal melanoma which is resistant to anti-tumor treatments and/or to take part to a research on resistance to cancer treatment;
  • To have read the information and signed the informed consent.

排除标准

  • Patients & parents of a sick child:
  • To have difficulties in understanding the French language.
  • Have or have had cancer (criteria only for parents);
  • Pregnant woman, likely to be pregnant or breastfeeding (criteria only for patients).
  • Persons deprived of their liberty or under guardianship;
  • Impossibility of study requirements respect for geographical, social or psychological reasons.
  • Expert patients:
  • To have difficulties in understanding the French language ;
  • Currently being undergoing anti-tumor treatment.
  • Professionals:
  • To have difficulties in understanding the French language ;
  • Not to be confronted in professional practice with resistance to anti-tumor treatments.

结局指标

主要结局

Acceptability of the booklet evaluated

时间窗: 18 months

Items and issues revised and reformulated by the experts. Application of the booklet in the determined clinic: Modes of administration of the booklet and patients concerned identified. Implementation of the tool and relevant patients identified

List of patients' needs, particularly regarding communication with physicians

时间窗: 18 months

List of patients' needs in support, and information delivered by physicians in consultation

Items of communication booklet

时间窗: 18 months

Number and content of items, number of categories / themes,

Content of communication booklet validated

时间窗: 18 months

Consensus criteria: Consensus can be considered to have been reached if the majority of participants (70% or more) rank an item similarly

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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