Pancreatic Cancer Clinical Trial
— COMMUNICAREOfficial title:
COMMUNI.CARE (COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer): Study Protocol
Verified date | October 2023 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
BACKGROUND: The diagnosis of pancreatic adenocarcinoma (PDAC) in many cases is completely unforeseen by the patient, who often faces a disease that is already at an advanced stage, with poor prognosis. The clinical visit during which the diagnosis is communicated together with the first information regarding the planned treatments is of paramount importance. It is hypothesized that the clarity of such information is able to influence patients's engagement and thus the compliance. AIMS: The aim of this study is to collect quantitative data on the level of PDAC patient engagement and the rate of understanding of the information received from the doctor, and investigate the possible association between these two variables and with the patient's level of compliance. METHODS: This is a single-center, observational, cross-sectional cohort study focused on patients diagnosed with PDAC, approved by the Ethics Committee of the San Raffaele Hospital. As no preliminary data are available on the association between PDAC patient's understanding rate and their level of engagement and of compliance no power calculation is possible. This is a pilot study, aimed at enrolling at least 45 PDAC patients during a 3 months frame. CONCLUSION: COMMUNI.CARE will be the first study specifically investigating whether there is a relation between PDAC patients' rate of understanding, their engagement and compliance at time of diagnosis.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 19, 2022 |
Est. primary completion date | April 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (=18 years); - Of Italian mother tongue; - Have a histologic diagnosis of PDAC obtained during the 4 weeks before the visit - The visit is the first visit after completion of diagnostic procedures and is set to communicate the diagnosis and treatment strategies - Give full, written informed consent Exclusion Criteria: - PDAC recurrence after previous diagnosis and treatment - Poor performance status (ECOG = 3 |
Country | Name | City | State |
---|---|---|---|
Italy | Gabriele Capurso | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Engagement Level | Patient Health Engagement Scale (PHE-S®)-Scale is a validated quantitative tool to measure engagement. | 3 months | |
Primary | Patient's Rate of Understanding | a semi-structured interview of about 30 minutes to ask the patient questions concerning the clarity of the communication he had received from the doctor and the type of language used, to record the rate of understanding of the information will be employed to define whether the language used by the treating physician and its clarity for the patient allowed understanding defined as the rate. | 3 months | |
Primary | Patient's Compliance | Defined as rate of therapies received compared to what was proposed and planned by the treating physicians. | 6 months |
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