Pancreatic CancerCOMMUNICARENCT04257955
COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer
An observational study of Pancreatic Cancer and Interaction, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Interaction, Diagnosis
- What is being tested?
- Interview and evaluation of Engagement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2020to 19 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- PDAC recurrence after previous diagnosis and treatment
- Poor performance status (ECOG ≥ 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMMUNI.CARE (COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer): Study Protocol
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.
Read more
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Interaction, Diagnosis
- Being tested
- Interview and evaluation of Engagement
- Keywords
- doctor- patient interaction, pancreatic cancer, diagnosis communication
- Medical subject headings
- Pancreatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview and evaluation of EngagementBehavioural
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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); Receives: Behavioral: Interview and evaluation of Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Engagement Level
Patient Health Engagement Scale (PHE-S®)-Scale is a validated quantitative tool to measure engagement.
Measured: 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.
Measured: 3 months
Patient's Compliance
Defined as rate of therapies received compared to what was proposed and planned by the treating physicians.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start15 Sep 2020
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Capurso, IRCCS San Raffaele
- Investigators
- Gabriele Capurso, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257955
- Sponsor's protocol ID
- 51/INT/2019
- Acronym
- COMMUNICARE
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMMUNI.CARE (COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer): Study Protocol
- ClinicalTrials.gov ID
- NCT04257955
- Acronym / sponsor ID
- COMMUNICARE / 51/INT/2019
- Conditions
- Pancreatic Cancer, Interaction, Diagnosis
- Keywords
- doctor- patient interaction, pancreatic cancer, diagnosis communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | – | Behavioral: Interview and evaluation of EngagementOutpatients 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); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- PDAC recurrence after previous diagnosis and treatment
- Poor performance status (ECOG ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview and evaluation of Engagement(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. | Behavioural | Pancreatic cancer |
Primary outcome
Patient Engagement Level
Time frame: 3 months
Patient Health Engagement Scale (PHE-S®)-Scale is a validated quantitative tool to measure engagement.
Patient's Rate of Understanding
Time frame: 3 months
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.
Patient's Compliance
Time frame: 6 months
Defined as rate of therapies received compared to what was proposed and planned by the treating physicians.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Capurso principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Interaction, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Engagement Level (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.