Metastatic Uveal MelanomaNCT04118062
Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
A study testing Questionnaires, Semi-structured individual interviews and Focus Group in people with Metastatic Uveal Melanoma and Triple Negative Breast Cancer, run by Institut Curie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer
- What is being tested?
- Questionnaires, Semi-structured individual interviews and Focus Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- To be 18 years of age or older ;
- To have metastatic uveal melanoma (MUM) or triple negative or luminal B breast cancer ;
- To have received the information that the disease is resistant to treatment ;
- To have read the information and signed the informed consent.
- Parents of a sick child:
Show all 18Show fewer
- To be a parent (parental authority holder) of a child with cancer ;
- To have received the information that the child disease is resistant to treatment ;
- To have read the information and signed the informed consent.
- Expert patients:
- To be 18 years of age or older ;
- To have had cancer (regardless the cancer site) ;
- To participated to an expert patient training (fine knowledge of the illness, experience with the disease) ;
- To have read the information and signed the informed consent.
- Professionals:
- To be an oncologist (medical oncologist, surgeon, radiotherapist, supportive care specialist) and/or to be a researcher in oncology (doctor, biologist, geneticist ...) ;
- 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;
- To have read the information and signed the informed consent.
Who cannot join
- Patients \& parents of a sick child:
- To have difficulties in understanding the French language.
- Have or have had cancer (criteria only for parents);
- Pregnant woman, likely to be pregnant or breastfeeding (criteria only for patients).
- Persons deprived of their liberty or under guardianship;
- Impossibility of study requirements respect for geographical, social or psychological reasons.
Show all 12Show fewer
- Expert patients:
- To have difficulties in understanding the French language ;
- Currently being undergoing anti-tumor treatment.
- Professionals:
- To have difficulties in understanding the French language ;
- Not to be confronted in professional practice with resistance to anti-tumor treatments.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer, Pediatric Cancer
- Being tested
- Questionnaires, Semi-structured individual interviews, Focus Group, DELPHI Consensus Method
- Medical subject headings
- Uveal Melanoma, Triple Negative Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Questionnaires
Semi-structured individual interviewsBehavioural
Semi-structured individual interviews
Focus GroupOther
Focus Group
DELPHI Consensus MethodOther
DELPHI Consensus Method
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Uveal Melanoma | Other | Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma Receives: Behavioral: Questionnaires; Behavioral: Semi-structured individual interviews |
| Triple Negative Breast Cancer | Other | Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer Receives: Behavioral: Questionnaires; Behavioral: Semi-structured individual interviews |
| Luminal B Breast Cancer | Other | Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer Receives: Behavioral: Questionnaires; Behavioral: Semi-structured individual interviews |
| Pediatric Cancer | Other | Questionnaires and semi-structured individual interviews with parents of children with cancer. Receives: Behavioral: Questionnaires; Behavioral: Semi-structured individual interviews |
| Expert Patients | Other | Focus groups (or group interviews) and DELPHI consensus method with expert patients Receives: Other: Focus Group; Other: DELPHI Consensus Method |
| Researchers and Clinicians | Other | Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians Receives: Other: Focus Group; Other: DELPHI Consensus Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
List of patients' needs, particularly regarding communication with physicians
List of patients' needs in support, and information delivered by physicians in consultation
Measured: 18 months
Items of communication booklet
Number and content of items, number of categories / themes,
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start2 Feb 2021
- Primary completion26 May 2023
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie DOLBEAULT, PHD, Study director, Institut CurieAnne BREDART, PHD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118062
- Sponsor's protocol ID
- IC 2018-09
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets with interested reserachers, educators or clincians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Rault A, Dolbeault S, Terrasson J, Bouleuc C, Cottu P, Piperno-Neumann S, Rodrigues M, Vaflard P, Bredart A. Facilitating patient-oncologist communication in advanced treatment-resistant cancer: development and feasibility testing of a question prompt list. Pilot Feasibility Stud. 2024 Aug 28;10(1):116. doi: 10.1186/s40814-024-01543-y.
PubMed 39198868Bredart 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.
PubMed 35019850
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04118062
- Acronym / sponsor ID
- IC 2018-09
- Conditions
- Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer, Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metastatic Uveal Melanoma | Other | Behavioral: Questionnaires, Behavioral: Semi-structured individual interviewsQuestionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma |
| Triple Negative Breast Cancer | Other | Behavioral: Questionnaires, Behavioral: Semi-structured individual interviewsQuestionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer |
| Luminal B Breast Cancer | Other | Behavioral: Questionnaires, Behavioral: Semi-structured individual interviewsQuestionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer |
| Pediatric Cancer | Other | Behavioral: Questionnaires, Behavioral: Semi-structured individual interviewsQuestionnaires and semi-structured individual interviews with parents of children with cancer. |
| Expert Patients | Other | Other: Focus Group, Other: DELPHI Consensus MethodFocus groups (or group interviews) and DELPHI consensus method with expert patients |
| Researchers and Clinicians | Other | Other: Focus Group, Other: DELPHI Consensus MethodFocus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients:
- Parents of a sick child:
- Expert patients:
- Professionals:
Key exclusion criteria (12 listed)
- Patients \& parents of a sick child:
- Expert patients:
- Professionals:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires | Behavioural | Luminal B Breast Cancer, Metastatic Uveal Melanoma, Pediatric Cancer, Triple Negative Breast Cancer |
| Semi-structured individual interviewsSemi-structured individual interviews | Behavioural | Luminal B Breast Cancer, Metastatic Uveal Melanoma, Pediatric Cancer, Triple Negative Breast Cancer |
| Focus GroupFocus Group | Other | Expert Patients, Researchers and Clinicians |
| DELPHI Consensus MethodDELPHI Consensus Method | Other | Expert Patients, Researchers and Clinicians |
Primary outcome
List of patients' needs, particularly regarding communication with physicians
Time frame: 18 months
List of patients' needs in support, and information delivered by physicians in consultation
Items of communication booklet
Time frame: 18 months
Number and content of items, number of categories / themes,
Acceptability of the booklet evaluated
Time frame: 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
Content of communication booklet validated
Time frame: 18 months
Consensus criteria: Consensus can be considered to have been reached if the majority of participants (70% or more) rank an item similarly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 39198868Rault A, Dolbeault S, Terrasson J, Bouleuc C, Cottu P, Piperno-Neumann S, Rodrigues M, Vaflard P, Bredart A. Facilitating patient-oncologist communication in advanced treatment-resistant cancer: development and feasibility testing of a question prompt list. Pilot Feasibility Stud. 2024 Aug 28;10(1):116. doi: 10.1186/s40814-024-01543-y.
- Derived from this study: PubMed 35019850Bredart 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.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets with interested reserachers, educators or clincians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Metastatic Uveal Melanoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Not yet recruitingPhase 1/2
Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors
Advanced Solid Tumors
Active, not recruitingPhase 1/2
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Melanoma Metastatic, Melanoma of Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie DOLBEAULT, PHD study director
Institut Curie
Anne BREDART, PHD study director
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Semi-structured individual interviews and Focus Group in people with Metastatic Uveal Melanoma and Triple Negative Breast Cancer, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of patients' needs, particularly regarding communication with physicians (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.