Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729230
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2023-02-06
Brief Title:
PAtient-PHYsician Relationship Assessment
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Evaluation of the Patient-physician Relationship During the Initial Consultation Prior to the Introduction of a New Systemic Treatment for Advanced Hepatocellular Carcinoma Information Needs Prognostic Awareness Treatment Expectations Regarding Efficacy and Side Effects
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
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:
PAPHYRA
Brief Summary:
I Introduction Patients with cancer face difficult choices that require balancing competing priorities such as survival functional capacity and symptom relief Most patients with advanced cancer 80 expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process Nevertheless this kind of discussion is frequently lacking and consequently patients often have a biased view of their own prognosis such as an underestimation of disease severity or unrealistic expectations for cure
Patients with advanced hepatocellular carcinoma HCC may be treated with systemic therapies which may prolong survival but are not curative Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician Accordingly communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions To the best of our knowledge a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients
The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy
II Type of study
Prospective observational non-interventional multicentric study
III Outcomes III1 Primary Outcome Evaluate the concordance between the patients perception of his prognosis and treatment side effects with the one of his treating physician
III2 Secondary Outcomes
Compare the patients expectations for the aforementioned items to those of his physician and the degree of concordance between them
Evaluation of patient satisfaction with the information received during the consultation
Assessment of patient-reported symptoms of anxiety and depression
Evaluate the association between individual prognosis expectation ie patient and physician and data from the available literature
IV Recruitment All consecutive patients with a new systemic treatment prescribed for HCC in participating centres will be included for a period of 1 year
Patients with advanced hepatocellular carcinoma HCC may be treated with systemic therapies which may prolong survival but are not curative Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician Accordingly communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions To the best of our knowledge a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients
The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy
II Type of study
Prospective observational non-interventional multicentric study
III Outcomes III1 Primary Outcome Evaluate the concordance between the patients perception of his prognosis and treatment side effects with the one of his treating physician
III2 Secondary Outcomes
Compare the patients expectations for the aforementioned items to those of his physician and the degree of concordance between them
Evaluation of patient satisfaction with the information received during the consultation
Assessment of patient-reported symptoms of anxiety and depression
Evaluate the association between individual prognosis expectation ie patient and physician and data from the available literature
IV Recruitment All consecutive patients with a new systemic treatment prescribed for HCC in participating centres will be included for a period of 1 year
Detailed Description:
Patients with cancer face difficult choices that require balancing competing priorities such as survival functional capacity and symptom relief Most patients with advanced cancer 80 expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process Nevertheless this kind of discussion is frequently lacking and consequently patients often have a biased view of their own prognosis such as an underestimation of disease severity or unrealistic expectations for cure
Patients with advanced hepatocellular carcinoma HCC may be treated with systemic therapies which may prolong survival but are not curative Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician Accordingly communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions To the best of our knowledge a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients
The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy
Patients with advanced hepatocellular carcinoma HCC may be treated with systemic therapies which may prolong survival but are not curative Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician Accordingly communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions To the best of our knowledge a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients
The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy
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