CClinicalTrials.gg
CompletedNCT04118062Updated Sep 19, 2025

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

An interventional study of Questionnaires and Semi-structured individual interviews in Metastatic Uveal Melanoma, Triple Negative Breast Cancer and Luminal B Breast Cancer, sponsored by Institut Curie. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Institut Curie · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Metastatic Uveal Melanoma
  • Triple Negative Breast Cancer
  • Luminal B Breast Cancer
  • Pediatric Cancer
03

In context

Uveal Melanoma

103 studies on the registry are indexed under Uveal Melanoma; 38 are open to participants now.

This study's enrollment of 128 is above the median of 42 across 93 interventional studies indexed under Uveal Melanoma.

Browse Uveal Melanoma studies →

Lead sponsor

Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • Other
    Metastatic Uveal Melanoma

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

    Behavioral: Questionnaires · Behavioral: Semi-structured individual interviews

  • Other
    Triple Negative Breast Cancer

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

    Behavioral: Questionnaires · Behavioral: Semi-structured individual interviews

  • Other
    Luminal B Breast Cancer

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

    Behavioral: Questionnaires · Behavioral: Semi-structured individual interviews

  • Other
    Pediatric Cancer

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

    Behavioral: Questionnaires · Behavioral: Semi-structured individual interviews

  • Other
    Expert Patients

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

    Other: Focus Group · Other: DELPHI Consensus Method

  • Other
    Researchers and Clinicians

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

    Other: Focus Group · Other: DELPHI Consensus Method

Interventions

  • BehavioralQuestionnaires

    Questionnaires

  • BehavioralSemi-structured individual interviews

    Semi-structured individual interviews

  • OtherFocus Group

    Focus Group

  • OtherDELPHI Consensus Method

    DELPHI Consensus Method

06

What researchers measure

Primary outcomes

  1. List of patients' needs, particularly regarding communication with physicians

    List of patients' needs in support, and information delivered by physicians in consultation

    Time frame: 18 months

  2. Items of communication booklet

    Number and content of items, number of categories / themes,

    Time frame: 18 months

  3. 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

    Time frame: 18 months

  4. 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

    Time frame: 18 months

07

Study locations

1 site
  • Institut Curie
    Paris, 75005, France
08

References and documents

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 39198868 ↗
  • Bredart 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04118062
Lead sponsor
Institut Curie
Responsible party
Sponsor
First posted
Oct 7, 2019
Start date
Feb 2, 2021
Primary completion
May 26, 2023
Completion
May 26, 2024
Last update
Sep 19, 2025

Study contacts

Sylvie DOLBEAULT, PHD
study director · Institut Curie
Anne BREDART, PHD
study director · Institut Curie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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