Back to resultsCommunicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
Primary Purpose
Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Semi-structured individual interviews
Focus Group
DELPHI Consensus Method
Sponsored by
About this trial
This is an interventional other trial for Metastatic Uveal Melanoma
Eligibility Criteria
Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
Metastatic Uveal Melanoma
Triple Negative Breast Cancer
Luminal B Breast Cancer
Pediatric Cancer
Expert Patients
Researchers and Clinicians
Arm Description
Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma
Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer
Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer
Questionnaires and semi-structured individual interviews with parents of children with cancer.
Focus groups (or group interviews) and DELPHI consensus method with expert patients
Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians
Outcomes
Primary Outcome Measures
List of patients' needs, particularly regarding communication with physicians
List of patients' needs in support, and information delivered by physicians in consultation
Items of communication booklet
Number and content of items, number of categories / themes,
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04118062
Brief Title
Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
May 26, 2023 (Actual)
Study Completion Date
May 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Uveal Melanoma, Triple Negative Breast Cancer, Luminal B Breast Cancer, Pediatric Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metastatic Uveal Melanoma
Arm Type
Other
Arm Description
Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma
Arm Title
Triple Negative Breast Cancer
Arm Type
Other
Arm Description
Questionnaires and semi-structured individual interviews with patients with Triple Negative Breast Cancer
Arm Title
Luminal B Breast Cancer
Arm Type
Other
Arm Description
Questionnaires and semi-structured individual interviews with patients with Luminal B Breast Cancer
Arm Title
Pediatric Cancer
Arm Type
Other
Arm Description
Questionnaires and semi-structured individual interviews with parents of children with cancer.
Arm Title
Expert Patients
Arm Type
Other
Arm Description
Focus groups (or group interviews) and DELPHI consensus method with expert patients
Arm Title
Researchers and Clinicians
Arm Type
Other
Arm Description
Focus groups (or group interviews) and DELPHI consensus method with Researchers and Clinicians
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Semi-structured individual interviews
Intervention Description
Semi-structured individual interviews
Intervention Type
Other
Intervention Name(s)
Focus Group
Intervention Description
Focus Group
Intervention Type
Other
Intervention Name(s)
DELPHI Consensus Method
Intervention Description
DELPHI Consensus Method
Primary Outcome Measure Information:
Title
List of patients' needs, particularly regarding communication with physicians
Description
List of patients' needs in support, and information delivered by physicians in consultation
Time Frame
18 months
Title
Items of communication booklet
Description
Number and content of items, number of categories / themes,
Time Frame
18 months
Title
Acceptability of the booklet evaluated
Description
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
Title
Content of communication booklet validated
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie DOLBEAULT, PHD
Organizational Affiliation
Institut Curie
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne BREDART, PHD
Organizational Affiliation
Institut Curie
Official's Role
Study Director
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35019850
Citation
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.
Results Reference
derived
Learn more about this trial
Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)
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