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

Crises Situations That the Patients and Caregivers Confront in Daily Practice Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736940
• Other study ID #: En attente de promotion
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Zahra CASTEL AJGAL, MD
• Phone: +33 1 58 41 42 13
• Email: zahra.ajgal[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: November 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crises Situations That the Patients and Caregivers Confront in Daily Practice

Locations

Country	Name	City	State
France	APHP Assistance Publique des Hôpitaux de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Canceropôle Ile de France

Country where clinical trial is conducted

France, 

References & Publications (16)

Back AL, Arnold RM. Dealing with conflict in caring for the seriously ill: "it was just out of the question". JAMA. 2005 Mar 16;293(11):1374-81. — View Citation

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. — View Citation

Bochatay N, Bajwa NM, Cullati S, Muller-Juge V, Blondon KS, Junod Perron N, Maître 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. — View Citation

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;6:E5. doi:10.1186/1472-6939-6-5.

Carnevale FA, Farrell C, Cremer R, Canoui P, Séguret S, Gaudreault J, de Bérail 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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Hsu C-C, Sandford BA. The Delphi Technique: Making Sense Of Consensus n.d.;12:8.

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. — View Citation

Knickle K, McNaughton N, Downar J. Beyond winning: mediation, conflict resolution, and non-rational sources of conflict in the ICU. Crit Care Lond Engl 2012;16:308. doi:10.1186/CC11141.

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/ .

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	List of crises ranked by order of importance in each group of paticipant		1 month