- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04736940
Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers. The COPE Study. (COPE) (COPE)
Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zahra CASTEL AJGAL, MD
- Phone Number: +33 1 58 41 42 13
- Email: zahra.ajgal@aphp.fr
Study Contact Backup
- Name: Eric DUFOUR
- Phone Number: 01 58 41 12 11
- Email: eric.dufour@aphp.fr
Study Locations
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-
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Paris, France, 75004
- Recruiting
- APHP Assistance Publique des Hôpitaux de Paris
-
Contact:
- Zahra CASTEL AJGAL, MD
- Email: zahra.ajgal@aphp.fr
-
Contact:
- Olivier HUILLARD, PhD
- Phone Number: 01 58 41 29 92
- Email: olivier.huillard@aphp.fr
-
Principal Investigator:
- Zahra CASTEL AJGAL, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
List of crises ranked by order of importance in each group of paticipant
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
General Publications
- Carnevale FA, Farrell C, Cremer R, Canoui P, Seguret S, Gaudreault J, de Berail B, Lacroix J, Leclerc F, Hubert P. Struggling to do what is right for the child: pediatric life-support decisions among physicians and nurses in France and Quebec. J Child Health Care. 2012 Jun;16(2):109-23. doi: 10.1177/1367493511420184. Epub 2012 Jan 13.
- Coast J, Bailey C, Orlando R, Armour K, Perry R, Jones L, Kinghorn P. Adaptation, Acceptance and Adaptive Preferences in Health and Capability Well-Being Measurement Amongst Those Approaching End of Life. Patient. 2018 Oct;11(5):539-546. doi: 10.1007/s40271-018-0310-z.
- Hong P, Maguire E, Purcell M, Ritchie KC, Chorney J. Decision-Making Quality in Parents Considering Adenotonsillectomy or Tympanostomy Tube Insertion for Their Children. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):260-266. doi: 10.1001/jamaoto.2016.3365.
- Bochatay N, Bajwa NM, Cullati S, Muller-Juge V, Blondon KS, Junod Perron N, Maitre F, Chopard P, Vu NV, Kim S, Savoldelli GL, Hudelson P, Nendaz MR. A Multilevel Analysis of Professional Conflicts in Health Care Teams: Insight for Future Training. Acad Med. 2017 Nov;92(11S Association of American Medical Colleges Learn Serve Lead: Proceedings of the 56th Annual Research in Medical Education Sessions):S84-S92. doi: 10.1097/ACM.0000000000001912.
- Walrath JM, Dang D, Nyberg D. An organizational assessment of disruptive clinician behavior: findings and implications. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21. doi: 10.1097/NCQ.0b013e318270d2ba.
- Knickle K, McNaughton N, Downar J. Beyond winning: mediation, conflict resolution, and non-rational sources of conflict in the ICU. Crit Care. 2012 Jun 19;16(3):308. doi: 10.1186/CC11141.
- Back AL, Arnold RM. Dealing With Conflict in Caring for the Seriously Ill n.d.:8.
- Chiarchiaro J, White DB, Ernecoff NC, Buddadhumaruk P, Schuster RA, Arnold RM. Conflict Management Strategies in the ICU Differ Between Palliative Care Specialists and Intensivists. Crit Care Med. 2016 May;44(5):934-42. doi: 10.1097/CCM.0000000000001583.
- Park M, Jeon SH, Hong HJ, Cho SH. A comparison of ethical issues in nursing practice across nursing units. Nurs Ethics. 2014 Aug;21(5):594-607. doi: 10.1177/0969733013513212. Epub 2014 Jan 21.
- Breslin JM, MacRae SK, Bell J, Singer PA; University of Toronto Joint Centre for Bioethics Clinical Ethics Group. Top 10 health care ethics challenges facing the public: views of Toronto bioethicists. BMC Med Ethics. 2005 Jun 26;6:E5. doi: 10.1186/1472-6939-6-5.
- Killen AR, Fry ST, Damrosch S. Ethics and human rights issues in perioperative nurses: a subsample of Maryland nurses. Semin Perioper Nurs. 1996 Apr;5(2):77-83.
- Hsu C-C, Sandford BA. The Delphi Technique: Making Sense Of Consensus n.d.;12:8.
- Blackwood B, Albarran JW, Latour JM. Research priorities of adult intensive care nurses in 20 European countries: a Delphi study. J Adv Nurs. 2011 Mar;67(3):550-62. doi: 10.1111/j.1365-2648.2010.05512.x. Epub 2010 Nov 23.
- Meskell P, Murphy K, Shaw DG, Casey D. Insights into the use and complexities of the Policy Delphi technique. Nurse Res. 2014 Jan;21(3):32-9. doi: 10.7748/nr2014.01.21.3.32.e342.
- Démographie des professionnels de santé : qui sont les médecins en 2018 ? Quelle accessibilité aux médecins généralistes ? Combien d'infirmiers en 2040 ? Un outil de projections d'effectifs de médecins - Ministère des Solidarités et de la Santé n.d. http://drees.solidarites-sante.gouv.fr/etudes-et-statistiques/publications/communiques-de-presse/article/demographie-des-professionnels-de-sante-qui-sont-les-medecins-en-2018-quelle.
- La profession d'infirmière : situation démographique et trajectoires professionnelles - Data.gouv.fr n.d. /fr/datasets/la-profession-d-infirmiere-situation-demographique-et-trajectoires-professionnelles-30378340/ .
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- En attente de promotion
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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