Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)

Not Applicable

Active, not recruiting

• Conditions: Luminal B Breast Cancer; Metastatic Uveal Melanoma; Triple Negative Breast Cancer; Pediatric Cancer
• Interventions: Behavioral: Questionnaires; Other: Focus Group; Other: DELPHI Consensus Method; Behavioral: Semi-structured individual interviews

• Registration Number: NCT04118062
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Start: 2021-02-02
• Primary Completion: 2023-05-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04
• Study Completion: 2024-05-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 190

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Triple Negative Breast Cancer	Questionnaires	Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer
Expert Patients	Focus Group	Focus groups (or group interviews) and DELPHI consensus method with expert patients
Expert Patients	DELPHI Consensus Method	Focus groups (or group interviews) and DELPHI consensus method with expert patients
Metastatic Uveal Melanoma	Semi-structured individual interviews	Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma
Triple Negative Breast Cancer	Semi-structured individual interviews	Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer
Luminal B Breast Cancer	Semi-structured individual interviews	Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer
Pediatric Cancer	Semi-structured individual interviews	Questionnaires and semi-structured individual interviews with parents of children with cancer.
Luminal B Breast Cancer	Questionnaires	Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer
Pediatric Cancer	Questionnaires	Questionnaires and semi-structured individual interviews with parents of children with cancer.
Researchers and Clinicians	Focus Group	Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians
Researchers and Clinicians	DELPHI Consensus Method	Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians
Metastatic Uveal Melanoma	Questionnaires	Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma

Primary Outcome Measures

Name	Time	Method
Acceptability of the booklet evaluated	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	18 months	List of patients' needs in support, and information delivered by physicians in consultation
Items of communication booklet	18 months	Number and content of items, number of categories / themes,
Content of communication booklet validated	18 months	Consensus criteria: Consensus can be considered to have been reached if the majority of participants (70% or more) rank an item similarly

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France