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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Triple Negative Breast Cancer; Pediatric Cancer; Metastatic Uveal Melanoma; Luminal B Breast Cancer
• Intervention / Treatment: Behavioral: Questionnaires; Behavioral: Semi-structured individual interviews; Other: Focus Group; Other: DELPHI Consensus Method

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 Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna TERRASSON, PHD; Phone Number: 0033 1 44 32 42 71; Email: johanna.terrasson@curie.fr
• Study Contact Backup: Name: Anne-Claire COYNE, PhD; Phone Number: 0033 1 56 24 59 44; Email: anne-claire.coyne@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Sylvie DOLBEAULT, PHD, Institut Curie; Study Director: Anne BREDART, PHD, Institut Curie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): May 26, 2023
• Study Completion (Estimated): May 26, 2024

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Breast Neoplasms; Melanoma; Triple Negative Breast Neoplasms
• Other Study ID Numbers: IC 2018-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and will made accessible for up to 12 months.
• IPD Sharing 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No