Clinical trial NCT04823754: Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma "PERCEPTION1"
Official title: Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma, systemic treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.

Brief 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 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

Eligibility criteria: Inclusion Criteria:

1. Patient over 18 years of age
2. Patient informed and not objecting to participate in the study
3. Patient with advanced hepatocellular carcinoma.
4. Patient treated with systemic therapy

Exclusion Criteria:

1. Locoregional treatment combined with systemic treatment
2. Pregnancy in progress
3. Candidate for surgery or locoregional therapy
4. Patient with state medical aid (AME)

Primary outcomes:
measure: Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.
timeFrame: 12months
Secondary outcomes:
measure: Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
timeFrame: 12 months
measure: Evaluation of patient satisfaction with the information received during the consultation
timeFrame: 12 months
measure: Assessment of patient-reported symptoms of anxiety and depression
timeFrame: 12 months
measure: Evaluate the association between individual prognosis expectation (patient and physician) and data from the available literature.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
References:
citation: 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.
citation: Yennurajalingam 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.