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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2024-05-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Metastatic Uveal Melanoma

Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma

Group Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Semi-structured individual interviews

Intervention Type BEHAVIORAL

Semi-structured individual interviews

Triple Negative Breast Cancer

Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer

Group Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Semi-structured individual interviews

Intervention Type BEHAVIORAL

Semi-structured individual interviews

Luminal B Breast Cancer

Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer

Group Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Semi-structured individual interviews

Intervention Type BEHAVIORAL

Semi-structured individual interviews

Pediatric Cancer

Questionnaires and semi-structured individual interviews with parents of children with cancer.

Group Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Semi-structured individual interviews

Intervention Type BEHAVIORAL

Semi-structured individual interviews

Expert Patients

Focus groups (or group interviews) and DELPHI consensus method with expert patients

Group Type OTHER

Focus Group

Intervention Type OTHER

Focus Group

DELPHI Consensus Method

Intervention Type OTHER

DELPHI Consensus Method

Researchers and Clinicians

Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians

Group Type OTHER

Focus Group

Intervention Type OTHER

Focus Group

DELPHI Consensus Method

Intervention Type OTHER

DELPHI Consensus Method

Interventions

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Questionnaires

Intervention Type BEHAVIORAL

Semi-structured individual interviews

Intervention Type BEHAVIORAL

Focus Group

Intervention Type OTHER

DELPHI Consensus Method

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No