Hepatocellular CarcinomaPERCEPTION1NCT04823754
Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma "PERCEPTION1"
An observational study of Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jul 2021to 4 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.
Who may be able to join
- Patient over 18 years of age
- Patient informed and not objecting to participate in the study
- Patient with advanced hepatocellular carcinoma.
- Patient treated with systemic therapy
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
2 sites in 1 country.
France2 sites
Hôpital Avicenne
Bobigny, 93009
Assistance Publique - Hôpitaux de Paris
Paris
About this study
Official title: Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma
atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation
Read the detailed description
atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.
- Keywords
- hepatocellular carcinoma, 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.
Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.Other
Administation of two surveys to included patients, about the perception of the disease and the expectations related to the treatment.
The physician will be asked to complete a survey on his or her perception of the prognosis and information received by the patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 12months
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
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
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 (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start12 Jul 2021
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823754
- Sponsor's protocol ID
- APHP210481
- Acronym
- PERCEPTION1
- Status last verified
- Jun 2023
- First submitted
- 26 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loh KP, Mohile SG, Lund JL, Epstein R, Lei L, Culakova E, McHugh C, Wells M, Gilmore N, Mohamed MR, Kamen C, Aarne V, Conlin A, Bearden J 3rd, Onitilo A, Wittink M, Dale W, Hurria A, Duberstein P. Beliefs About Advanced Cancer Curability in Older Patients, Their Caregivers, and Oncologists. Oncologist. 2019 Jun;24(6):e292-e302. doi: 10.1634/theoncologist.2018-0890. Epub 2019 Apr 23.
PubMed 31015317Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20.
PubMed 29158371Nault JC, Sritharan N, Verset G, Borbath I, Lequoy M, Allaire M, Regnault H, Colle I, Orlent H, Sinapi I, Moreno C, Larrey E, Sidali S, Hollande C, Amaddeo G, Pol S, Nahon P, Ganne-Carrie N, Levy V, Bloch-Queyrat C; Paris Liver Cancer Group; Trepo E, Bouattour M. Patient and physician expectations regarding disease and treatment of advanced HCC: The prospective PERCEPTION1 study. JHEP Rep. 2024 Aug 22;6(11):101192. doi: 10.1016/j.jhepr.2024.101192. eCollection 2024 Nov.
PubMed 39741695
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04823754
- Acronym / sponsor ID
- PERCEPTION1 / APHP210481
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, systemic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 1 Apr 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.
atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation
Detailed description
atients 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 their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. 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, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Patient informed and not objecting to participate in the study
- Patient with advanced hepatocellular carcinoma.
- Patient treated with systemic therapy
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 |
|---|---|---|
| Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.Administation of two surveys to included patients, about the perception of the disease and the expectations related to the treatment. The physician will be asked to complete a survey on his or her perception of the prognosis and information received by the patient. | Other | – |
Primary outcome
Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.
Time frame: 12months
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
Evaluation of patient satisfaction with the information received during the consultation
Time frame: 12 months
Assessment of patient-reported symptoms of anxiety and depression
Time frame: 12 months
Evaluate the association between individual prognosis expectation (patient and physician) and data from the available literature.
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 11 Jul 2023.
- Background: PubMed 31015317Loh KP, Mohile SG, Lund JL, Epstein R, Lei L, Culakova E, McHugh C, Wells M, Gilmore N, Mohamed MR, Kamen C, Aarne V, Conlin A, Bearden J 3rd, Onitilo A, Wittink M, Dale W, Hurria A, Duberstein P. Beliefs About Advanced Cancer Curability in Older Patients, Their Caregivers, and Oncologists. Oncologist. 2019 Jun;24(6):e292-e302. doi: 10.1634/theoncologist.2018-0890. Epub 2019 Apr 23.
- Background: PubMed 29158371Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20.
- Derived from this study: PubMed 39741695Nault JC, Sritharan N, Verset G, Borbath I, Lequoy M, Allaire M, Regnault H, Colle I, Orlent H, Sinapi I, Moreno C, Larrey E, Sidali S, Hollande C, Amaddeo G, Pol S, Nahon P, Ganne-Carrie N, Levy V, Bloch-Queyrat C; Paris Liver Cancer Group; Trepo E, Bouattour M. Patient and physician expectations regarding disease and treatment of advanced HCC: The prospective PERCEPTION1 study. JHEP Rep. 2024 Aug 22;6(11):101192. doi: 10.1016/j.jhepr.2024.101192. eCollection 2024 Nov.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Assistance Publique - Hôpitaux de Paris at 2 sites 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 4 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician. (time frame: 12months). 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 NCT04823754, which also lists 3 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 11 Jul 2023.