Clinical trial · Observational
COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer
COMMUNI.CARE (COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer): Study Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnosis | — | UNRESOLVED | — |
| Interaction | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interview and evaluation of Engagement | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pancreatic cancer
- description
- Outpatients seen at the Gastroenterology, Pancreatic Surgery and Oncology Clinics of the Pancreas Translational and Clinical Research Centre, IRCCS San Raffaele, Milan (Italy) will be considered includable if: 1. Adult patients (≥18 years); 2. Of Italian mother tongue; 3. Have a histologic diagnosis of PDAC obtained during the 4 weeks before the visit 4. The visit is the first visit after completion of diagnostic procedures and is set to communicate the diagnosis and treatment strategies 5. Give full, written informed consent The following exclusion criteria will be applied: 1. PDAC recurrence after previous diagnosis and treatment 2. poor performance status (ECOG ≥ 3);
- interventionNames
- Behavioral: Interview and evaluation of Engagement
Primary outcomes (3)
- measure
- Patient Engagement Level
- timeFrame
- 3 months
- description
- Patient Health Engagement Scale (PHE-S®)-Scale is a validated quantitative tool to measure engagement.
- measure
- Patient's Rate of Understanding
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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