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

Triple Negative Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04118062
• Other study ID #: IC 2018-09
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: May 26, 2024

Study information

• Verified date: October 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: May 26, 2024
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Luminal B Breast Cancer
• Melanoma
• Metastatic Uveal Melanoma
• Pediatric Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Behavioral:
• Questionnaires
Questionnaires
• Semi-structured individual interviews
Semi-structured individual interviews

Other:
• Focus Group
Focus Group
• DELPHI Consensus Method
DELPHI Consensus Method

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

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