Crises Situations That the Patients and Caregivers Confront in Daily PracticeCOPENCT04736940
Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers. The COPE Study. (COPE)
An observational study of Crises Situations That the Patients and Caregivers Confront in Daily Practice, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crises Situations That the Patients and Caregivers Confront in Daily Practice
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- For patients: Patients who participate 1st step cannot participate to 2nd step
- For caregivers Caregivers who participate 1st step cannot participate to 2nd step.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP Assistance Publique des Hôpitaux de Paris
Paris, 75004
Zahra CASTEL AJGAL, MD, zahra.ajgal@aphp.fr
Olivier HUILLARD, PhD, 01 58 41 29 92, olivier.huillard@aphp.fr
About this study
Official title: Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.
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.
Read the 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.
- Keywords
- Conflict psychological, patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
List of crises ranked by order of importance in each group of paticipant
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Jun 2021
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Crises Situations That the Patients and Caregivers Confront in Daily PracticeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Cancéropôle Ile De France
- Responsible party
- Sponsor
- Investigators
- Olivier HUILLARD, PhD, Study chair, APHP Assistance Publique des Hôpitaux de ParisZahra CASTEL AJGAL, MD, Principal investigator, APHP Assistance Publique des Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736940
- Sponsor's protocol ID
- En attente de promotion
- Acronym
- COPE
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22247181Coast 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.
PubMed 29744765Hong 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.
PubMed 27930764Bochatay 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.
PubMed 29065028Walrath 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.
PubMed 23072933Knickle 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.
PubMed 22713247Back 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. doi: 10.1001/jama.293.11.1374.
PubMed 15769971Chiarchiaro 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.
PubMed 26765500Park 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.
PubMed 24449700Breslin 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.
PubMed 15978136Killen 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.
PubMed 8718399Hsu 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.
PubMed 21091912Meskell 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.
PubMed 24460564Démographie 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04736940
- Acronym / sponsor ID
- COPE / En attente de promotion
- Keywords
- Conflict psychological, patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Cancéropôle Ile De France
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- For patients: Patients who participate 1st step cannot participate to 2nd step
- For caregivers Caregivers who participate 1st step cannot participate to 2nd step.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
List of crises ranked by order of importance in each group of paticipant
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 22247181Carnevale 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.
- Background: PubMed 29744765Coast 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.
- Background: PubMed 27930764Hong 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.
- Background: PubMed 29065028Bochatay 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.
- Background: PubMed 23072933Walrath 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.
- Background: PubMed 22713247Knickle 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.
- Background: PubMed 15769971Back 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. doi: 10.1001/jama.293.11.1374.
- Background: PubMed 26765500Chiarchiaro 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.
- Background: PubMed 24449700Park 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.
- Background: PubMed 15978136Breslin 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.
- Background: PubMed 8718399Killen 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.
- BackgroundHsu C-C, Sandford BA. The Delphi Technique: Making Sense Of Consensus n.d.;12:8.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier HUILLARD, PhD study chair
APHP Assistance Publique des Hôpitaux de Paris
Zahra CASTEL AJGAL, MD principal investigator
APHP Assistance Publique des Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crises Situations That the Patients and Caregivers Confront in Daily Practice, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahra CASTEL AJGAL, MD (+33 1 58 41 42 13, zahra.ajgal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of crises ranked by order of importance in each group of paticipant (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736940, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.