Hepatocellular CarcinomaPAPHYRANCT05729230
PAtient-PHYsician Relationship Assessment
An observational study of Hepatocellular Carcinoma, run by Erasme University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Apr 2021to 31 Jan 2023
- 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
- Adult, Older adult
Study population: Patients with advanced hepatocellular carcinoma eligible for systemic treatment
Who may be able to join
- diagnose of advanced hepatocellular carcinoma by histology or radiology using the EASL criteria
- ≥ 18 years old
- willing to participate in the study, being capable of consenting and sign the informed consent
- not candidate for curative treatment or locoregional therapy
- any line systemic therapy that has been validated by the local hepatic tumor board.
Who cannot join
- Locoregional treatment combined with systemic treatment
- Pregnancy in progress
- Candidate for surgery or locoregional therapy
- Patient with state medical aid (AME)
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
Read more
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 III.1) Primary Outcome Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.
III.2) Secondary Outcomes
- Compare the patient's 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 (i.e., 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Questionnaire
- Keywords
- systemic treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Physician/data nurse and the patients will complete a questionnaire. The physician or data nurse must complete a descriptive form including the patient's age and gender as well as some information about the tumour and the underlying liver disease.
Based on the 4 open questions, patient will be classified into 2 groups after assessment of his answers by a group of digestive oncologists and psychologists. Group A includes patients with an accurate perception of the disease whereas group B will gather patients with unrealistic expectations. Psychosocial aspect, quality of the physician's communication, comprehension of the disease and treatment expectations are assessed by multiple-choice questions (Liker scale evaluation). Depression and anxiety were evaluated by the Hospital Anxiety and Depression Scale (HADS) that has been validated as a good scale with a high sensitivity and specificity for depression and anxiety for cancer patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of prognosis and treatment side effects
Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician. Use of survey completed by the patient and the doctors to assess the primary endpoint
Measured: 12 months
Secondary outcomes (4)
Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
Use of survey completed by the patient and the doctors to assess the primary endpoint
Measured: 12 months
Assessment of patient-reported symptoms of anxiety and depression
Use of survey completed by the patient and the doctors to assess the primary endpoint
Measured: 12 months
Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.
Use of survey completed by the patient and the doctors to assess the primary endpoint
Measured: 12 months
Evaluation of patient satisfaction with the information received during the consultation
Use of survey completed by the patient and the doctors to assess the primary endpoint
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 Apr 2021
- Primary completion26 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain, ASZ Aalst, Grand Hôpital de Charleroi, AZ Sint-Jan AV, CHC Montlegia
- Responsible party
- Sponsor
- Investigators
- Gontran Verset, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729230
- Sponsor's protocol ID
- P2020/448
- Acronym
- PAPHYRA
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05729230
- Acronym / sponsor ID
- PAPHYRA / P2020/448
- Conditions
- Hepatocellular Carcinoma
- Keywords
- systemic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain, ASZ Aalst, Grand Hôpital de Charleroi, AZ Sint-Jan AV, CHC Montlegia
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 15 Feb 2023 (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.
- 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 III.1) Primary Outcome Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.
III.2) Secondary Outcomes
- Compare the patient's 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 (i.e., 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced hepatocellular carcinoma eligible for systemic treatment
Key inclusion criteria (5 listed)
- diagnose of advanced hepatocellular carcinoma by histology or radiology using the EASL criteria
- ≥ 18 years old
- willing to participate in the study, being capable of consenting and sign the informed consent
- not candidate for curative treatment or locoregional therapy
- any line systemic therapy that has been validated by the local hepatic tumor board.
Key exclusion criteria (4 listed)
- Locoregional treatment combined with systemic treatment
- Pregnancy in progress
- Candidate for surgery or locoregional therapy
- Patient with state medical aid (AME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePhysician/data nurse and the patients will complete a questionnaire. The physician or data nurse must complete a descriptive form including the patient's age and gender as well as some information about the tumour and the underlying liver disease. Based on the 4 open questions, patient will be classified into 2 groups after assessment of his answers by a group of digestive oncologists and psychologists. Group A includes patients with an accurate perception of the disease whereas group B will gather patients with unrealistic expectations. Psychosocial aspect, quality of the physician's communication, comprehension of the disease and treatment expectations are assessed by multiple-choice questions (Liker scale evaluation). Depression and anxiety were evaluated by the Hospital Anxiety and Depression Scale (HADS) that has been validated as a good scale with a high sensitivity and specificity for depression and anxiety for cancer patients. | Behavioural | – |
Primary outcome
Perception of prognosis and treatment side effects
Time frame: 12 months
Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician. Use of survey completed by the patient and the doctors to assess the primary endpoint
4 secondary outcomes
Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
Time frame: 12 months
Assessment of patient-reported symptoms of anxiety and depression
Time frame: 12 months
Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.
Time frame: 12 months
Evaluation of patient satisfaction with the information received during the consultation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Gontran Verset, MD principal investigator
Universitair Ziekenhuis Brussel
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 Hepatocellular Carcinoma, run by Erasme University Hospital at 1 site in Belgium.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 15 Feb 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of prognosis and treatment side effects (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.