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Trial record 5 of 190 for:    hector

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

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ClinicalTrials.gov Identifier: NCT04118062
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Metastatic Uveal Melanoma Triple Negative Breast Cancer Luminal B Breast Cancer Pediatric Cancer Behavioral: Questionnaires Behavioral: Semi-structured individual interviews Other: Focus Group Other: DELPHI Consensus Method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Other
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.
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : February 2, 2022
Estimated Study Completion Date : February 2, 2023


Arm Intervention/treatment
Metastatic Uveal Melanoma
Questionnaires and semi-structured individual interviews with patients with Metastatic Uveal Melanoma
Behavioral: Questionnaires
Questionnaires

Behavioral: Semi-structured individual interviews
Semi-structured individual interviews

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

Behavioral: Semi-structured individual interviews
Semi-structured individual interviews

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

Behavioral: Semi-structured individual interviews
Semi-structured individual interviews

Pediatric Cancer
Questionnaires and semi-structured individual interviews with parents of children with cancer.
Behavioral: Questionnaires
Questionnaires

Behavioral: Semi-structured individual interviews
Semi-structured individual interviews

Expert Patients
Focus groups (or group interviews) and DELPHI consensus method with expert patients
Other: Focus Group
Focus Group

Other: DELPHI Consensus Method
DELPHI Consensus Method

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

Other: DELPHI Consensus Method
DELPHI Consensus Method




Primary Outcome Measures :
  1. 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

  2. Items of communication booklet [ Time Frame: 18 months ]
    Number and content of items, number of categories / themes,

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118062


Contacts
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Contact: Johanna TERRASSON, PHD 1 44 32 42 71 ext 0033 johanna.terrasson@curie.fr
Contact: Anne-Claire COYNE, PhD 1 56 24 59 44 ext 0033 anne-claire.coyne@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Sylvie DOLBEAULT, PHD       sylvie.dolbeault@curie.fr   
Principal Investigator: Sylvie DOLBEAUT, PHD         
Sponsors and Collaborators
Institut Curie
Investigators
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Study Director: Sylvie DOLBEAULT, PHD Institut Curie
Study Director: Anne BREDART, PHD Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04118062    
Other Study ID Numbers: IC 2018-09
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Melanoma
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas