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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04118062
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Curie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sylvie DOLBEAULT, PHDAnne BREDART, PHD
Principal Investigator Affiliation	Institut CurieInstitut Curie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer, Pediatric Cancer

Additional Details

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.

Arms & Interventions

Arms

Other: Metastatic Uveal Melanoma

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

Other: Triple Negative Breast Cancer

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

Other: Luminal B Breast Cancer

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

Other: Pediatric Cancer

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

Other: Expert Patients

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

Other: Researchers and Clinicians

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

Interventions

Behavioral: - Questionnaires

Questionnaires

Behavioral: - Semi-structured individual interviews

Semi-structured individual interviews

Other: - Focus Group

Focus Group

Other: - DELPHI Consensus Method

DELPHI Consensus Method

Contact a Trial Team

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International Sites

Institut Curie, Paris, France

Status

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Institut Curie

Paris, , 75005

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