Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04736940
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2021-01-29
Brief Title:
Definition of Crises in Medical Oncology a Two-way Perspective of Patients and Caregivers The COPE Study COPE
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Definition of Crises in Medical Oncology a Two-way Perspective of Patients and Caregivers a Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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 lifework 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
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 lifework 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None