Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
1 other identifier
interventional
128
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2024
CompletedSeptember 19, 2025
September 1, 2025
2.3 years
September 11, 2019
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
List of patients' needs, particularly regarding communication with physicians
List of patients' needs in support, and information delivered by physicians in consultation
18 months
Items of communication booklet
Number and content of items, number of categories / themes,
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
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
18 months
Study Arms (6)
Metastatic Uveal Melanoma
OTHERQuestionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma
Triple Negative Breast Cancer
OTHERQuestionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer
Luminal B Breast Cancer
OTHERQuestionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer
Pediatric Cancer
OTHERQuestionnaires and semi-structured individual interviews with parents of children with cancer.
Expert Patients
OTHERFocus groups (or group interviews) and DELPHI consensus method with expert patients
Researchers and Clinicians
OTHERFocus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians
Interventions
Questionnaires
Semi-structured individual interviews
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- +3 more criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (1)
Institut Curie
Paris, 75005, France
Related Publications (2)
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.
PMID: 39198868DERIVEDBredart 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.
PMID: 35019850DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sylvie DOLBEAULT, PHD
Institut Curie
- STUDY DIRECTOR
Anne BREDART, PHD
Institut Curie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
October 7, 2019
Study Start
February 2, 2021
Primary Completion
May 26, 2023
Study Completion
May 26, 2024
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data requests can be submitted starting 9 months after article publication and will made accessible for up to 12 months.
- Access Criteria
- Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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.