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Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers. The COPE Study. (COPE)

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Crises Situations That the Patients and Caregivers Confront in Daily Practice

Study type

Observational

Funder types

Other

Identifiers

NCT04736940
En attente de promotion

Details and patient eligibility

About

Our objective is to identify the main crises facing the patients and caregivers in medical oncology and rank them by order of importance. Each group of participant will also express its perception of other participants' list of crises.

Full description

Hypotheses:

Crises in medical oncology need to be precisely defined and classified. It should be the first step to offer appropriate support and solutions, improve communication and eventually improve quality of life/work for caregivers and for patients. Crises in medical oncology can imply all actors: doctors, nursing staff, psychologists, administration and patients. The definition of crisis and the level of importance of each situation may vary among these different groups. Nevertheless, we expect to identify shared characteristics. Patients' point of view which is rarely expressed will be collected. This work will also bring a better understanding of the perception each group have of each other.

Objectives:

Our main objective is to identify the main crises facing the patients and caregivers in medical oncology and rank them by order of importance. Each actor will also express its perception of other actors' list of crises.

Methods:

This work is led by an innovative multidisciplinary team of investigators associating patients, oncopsychologists, nurses and oncologists. Four study groups of participants are composed: a group of patients, a group of oncopsychologists, a group nurses and a group of oncologists.

Demographic characteristics, general characteristics of the disease for the patients or type of exercise for the caregivers are collected.

The first step of the project is to establish a list of crisis situations in each group consisting of 10 participants. The methodology applied is a modify Delphi in three rounds via a digital survey. In the first round, participants react to a pre-existing list, and are invited to complete it. The content is then analyzed, classified and developed into a list emailed for the second round.

In a second round, the participants establish a ranking of the items on a scale of 1-6 (not important to extremely important). The group of patients will then rank the items added by the caregivers, and vice-versa.

During the third and last round, the average of items is presented and the participants submit a new ranking. Individual interviews will be held to comment the results.

The second step of the project enables to widen the study population, with a minimal objective of 100 participants per group. These new participants receive the list established in the first step to grade 20 items per frequency and importance.

Enrollment

440 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • For patients: History of neoplasia or active treatment for a neoplasia of any localization of any phase.

No restriction of center of treatment >18 years old Written consent must be obtained before any data collection

  • For caregivers Being a doctor, nurse, or a psychooncologist No restriction of age, or seniority

Exclusion Criteria

  • For patients: Patients who participate 1st step cannot participate to 2nd step

  • For caregivers Caregivers who participate 1st step cannot participate to 2nd step.

Trial design

440 participants in 4 patient groups

Patients
Description:
Patients followed or currently treated for a solid or haematological neoplasia
Doctors
Description:
Medical oncologist or haematologist
Paramedical staff
Description:
Nurses or assistant nurses
Oncopsychologist
Description:
Psychologist specialised in the care of patients with cancer

Trial contacts and locations

1

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Central trial contact

Zahra CASTEL AJGAL, MD; Eric DUFOUR

Data sourced from clinicaltrials.gov

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