Clinical trial NCT04257955: COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer
Official title: COMMUNI.CARE (COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer): Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Interaction
Diagnosis
Keywords: doctor- patient interaction
pancreatic cancer
diagnosis communication
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (\<18 years old), Italian mother tongue, enrolled during the visit that takes place at the time of the communication of the pancreatic cancer diagnosis

Brief summary: 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.

Detailed description: The diagnosis of PDAC in most cases is completely unforeseen for the patient, who faces with the disease already at an advanced stage and without a progressive approach to it. The clinical interview in which the diagnosis and the first information regarding treatment options and prognosis are communicated assumes a strong relevance, since it is an unexpected diagnosis with a poor prognosis.

Doctor-patient communication is an integral part of the care itself and poses the basis for the construction of the therapeutic alliance, an essential condition for compliance of the patient with reference to the treatments proposed by the physician.

Many recent studies claim that a good level of patient engagement is an essential condition for building a solid therapeutic alliance; in this regard, objective measurement scales of the patient engagement level have been developed, and have been demonstrated to be useful for quantifying the patient's involvement within the care process Among them is the Patient Health Engagement Scale (PHE-S®)-Scale, a recently validated assessment scale of simple and non-invasive use, that requires only the administration of a questionnaire to the previously informed patient who gives his consent.

The hypothesis of this study is that the clarity of the communication between the treating physician and the patient, and the level of understanding by the patient of the information conveyed by the doctor, in particular at the time of diagnosis largely influences the construction of a solid therapeutic alliance between the treating physician and PDAC patients and consequently the patient's engagement and compliance in the care process.

Our hypothesis is that the clarity of the communication between the treating physician and the patient and the degree of comprehension by the patient, especially during the first phases of the cure, are associated with the level of engagement and consequently with the compliance of patients with PDAC.

If the present pilot study will support the initial hypothesis, further action to improve the clarity of the clinical communication will be promoted.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Engagement Level
timeFrame: 3 months
measure: Patient's Rate of Understanding
timeFrame: 3 months
measure: Patient's Compliance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Gabriele Capurso
Study officials:
affiliation: IRCCS San Raffaele
name: Gabriele Capurso
role: PRINCIPAL_INVESTIGATOR
References: