COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer

NCT04257955 | Completed

• 1 other identifier: 51/INT/2019
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Interaction; Diagnosis

Keywords

doctor- patient interaction; pancreatic cancer; diagnosis communication

Outcome Measures

Primary Outcomes (3)

• Patient Engagement Level

  Patient Health Engagement Scale (PHE-S®)-Scale is a validated quantitative tool to measure engagement.

  3 months

• 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

• Patient's Compliance

  Defined as rate of therapies received compared to what was proposed and planned by the treating physicians.

  6 months

Study Arms (1)

Pancreatic cancer

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);

Behavioral: Interview and evaluation of Engagement

Interventions

Interview and evaluation of Engagement BEHAVIORAL

(i) the completion of the scheduled outpatients visit (ii) filling of the PHE-Scale® questionnaire by the patient to investigate the level of engagement and (iii) the completion of a semi-structured interview to assess the rate of understanding of the information received from the doctor.

Pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• PDAC recurrence after previous diagnosis and treatment
• Poor performance status (ECOG ≥ 3

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Gabriele Capurso

Milan, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gabriele Capurso

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief of Clinical Research, Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Centre, San Raffaele Scientific Institute, Milan, Italy

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: September 15, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

IT (1)