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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04736940

Collaborator

Canceropôle Ile de France (Other)

440

Enrollment

Location

Anticipated Duration (Months)

25.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crises Situations That the Patients and Caregivers Confront in Daily Practice

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

440 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

List of crises ranked by order of importance in each group of paticipant [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	APHP Assistance Publique des Hôpitaux de Paris	Paris		France	75004

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
Canceropôle Ile de France

Investigators

Study Chair: Olivier HUILLARD, PhD, APHP Assistance Publique des Hôpitaux de Paris
Principal Investigator: Zahra CASTEL AJGAL, MD, APHP Assistance Publique des Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04736940

Other Study ID Numbers:

En attente de promotion

First Posted:

Feb 3, 2021

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Conflict psychological

patients

Study Results

No Results Posted as of Feb 18, 2022