Clinical trial NCT04736940: Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers. The COPE Study. (COPE)
Official title: Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crises Situations That the Patients and Caregivers Confront in Daily Practice
Keywords: Conflict psychological
patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Canceropôle Ile de France
First posted: 2021-02-03
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from public or private clinics or hospitals involved in oncology in France Communication on the study to recruit participants is done widely via professional of patients' networks

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: List of crises ranked by order of importance in each group of paticipant
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Assistance Publique des Hôpitaux de Paris
Study officials:
affiliation: APHP Assistance Publique des Hôpitaux de Paris
name: Olivier HUILLARD, PhD
role: STUDY_CHAIR
affiliation: APHP Assistance Publique des Hôpitaux de Paris
name: Zahra CASTEL AJGAL, MD
role: PRINCIPAL_INVESTIGATOR
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