Clinical trial NCT04118062: Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Uveal Melanoma
Triple Negative Breast Cancer
Luminal B Breast Cancer
Pediatric Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: To meet our objectives, the research team has developed a cross-sectional and mixed exploratory research according to three successive steps :

Step 1: Questionnaires and semi-structured individual interviews will : (a) to identify patients' needs and (b) to build the initial contents of the tool, items and issues. Four patients' populations will be recruited in this step : metastatic uveal melanoma, triple negative breast cancer, luminal B breast cancer, and pediatric cancer. This step will be conducted in parallel with these populations.

Step 2 : Focus groups : to evaluate the acceptability and applicability of the tool in this clinical context with expert patients, researchers and clinicians.

Step 3 : The DELPHI consensus method : to validate the contents of the booklet for patients with expert patients, researchers and clinicians.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients:

  1. To be 18 years of age or older ;
  2. To have metastatic uveal melanoma (MUM) or triple negative or luminal B breast cancer ;
  3. To have received the information that the disease is resistant to treatment ;
  4. To have read the information and signed the informed consent.
* Parents of a sick child:

  1. To be a parent (parental authority holder) of a child with cancer ;
  2. To have received the information that the child disease is resistant to treatment ;
  3. To have read the information and signed the informed consent.
* Expert patients:

  1. To be 18 years of age or older ;
  2. To have had cancer (regardless the cancer site) ;
  3. To participated to an expert patient training (fine knowledge of the illness, experience with the disease) ;
  4. To have read the information and signed the informed consent.
* Professionals:

  1. To be an oncologist (medical oncologist, surgeon, radiotherapist, supportive care specialist) and/or to be a researcher in oncology (doctor, biologist, geneticist ...) ;
  2. 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;
  3. To have read the information and signed the informed consent.

Exclusion Criteria:

* Patients \& parents of a sick child:

  1. To have difficulties in understanding the French language.
  2. Have or have had cancer (criteria only for parents);
  3. Pregnant woman, likely to be pregnant or breastfeeding (criteria only for patients).
  4. Persons deprived of their liberty or under guardianship;
  5. Impossibility of study requirements respect for geographical, social or psychological reasons.
* Expert patients:

  1. To have difficulties in understanding the French language ;
  2. Currently being undergoing anti-tumor treatment.
* Professionals:

  1. To have difficulties in understanding the French language ;
  2. Not to be confronted in professional practice with resistance to anti-tumor treatments.

Primary outcomes:
measure: List of patients' needs, particularly regarding communication with physicians
timeFrame: 18 months
measure: Items of communication booklet
timeFrame: 18 months
measure: Acceptability of the booklet evaluated
timeFrame: 18 months
measure: Content of communication booklet validated
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Sylvie DOLBEAULT, PHD
role: STUDY_DIRECTOR
affiliation: Institut Curie
name: Anne BREDART, PHD
role: STUDY_DIRECTOR
References:
citation: Bredart A, Rault A, Terrasson J, Seigneur E, De Koning L, Hess E, Savignoni A, Cottu P, Pierga JY, Piperno-Neumann S, Rodrigues M, Bouleuc C, Dolbeault S. Helping Patients Communicate With Oncologists When Cancer Treatment Resistance Occurs to Develop, Test, and Implement a Patient Communication Aid: Sequential Collaborative Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e26414. doi: 10.2196/26414.