Ductal Adenocarcinoma of PancreasNCT07532590
Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content (PancreasPlus).
A study testing use of PancreasPlus app in people with Ductal Adenocarcinoma of Pancreas and Pancreatectomy, run by Casa di Cura Dott. Pederzoli at 2 sites in Italy.
Trial summary
Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Adenocarcinoma of Pancreas, Pancreatectomy, Caregiver
- What is being tested?
- use of PancreasPlus app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Feb 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18; diagnosis of pancreatic cancer (histological/cytological)
- Access to a smartphone or tablet and a data connection; basic digital literacy or a caregiver available,
- Ability to understand and provide informed consent; understanding of the Italian language.
Who cannot join
- Severe uncompensated cognitive impairment,
- Social or logistical circumstances that prevent follow-up or access to/use of the app,
- Refusal or withdrawal of consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Active, not recruiting
U.O. Chirurgia Generale 1, IRCCS San Matteo, Università degli Studi di Pavia
Pavia, Pavia, 27100
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Giovanni Butturini, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: A Prospective Study on the Use of an App (PancreasPlus) for Home Monitoring and Proactive Management of Patients With Pancreatic Cancer.
Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. However, this active involvement can be difficult if there is poor communication with healthcare teams, differences in skills or familiarity with digital tools, or systems that do not support patient participation.
The PancreasPlus app was developed to support patients and caregivers by providing reliable information, self-monitoring tools, and a communication channel with healthcare professionals. The study aims to assess the feasibility, patient engagement, and perceived quality of routine use of the app. It is hypothesized that its use will improve engagement, perceived quality, reduce anxiety and unplanned hospital visits, without introducing technological or privacy risks. The app supports information and data collection but does not replace clinical decision-making.
Read more
Objectives
Primary objectives:
Assess feasibility and patient engagement through questionnaire completion. Evaluate perceived service quality using the Client Satisfaction Questionnaire (CSQ-8).
Secondary objectives:
Monitor unplanned hospital visits and adherence to chemotherapy. Assess anxiety (HADS-A), nutritional status, and global quality of life (PROMIS Global).
Evaluate usability and acceptability of the app (SUS, UTAUT2 short version).
Endpoints Primary endpoints include questionnaire completion rates and perceived quality (CSQ-8 score). Secondary endpoints include unplanned hospital access, chemotherapy adherence, anxiety levels, nutritional status, quality of life, and app usability/acceptability.
Methods This is a prospective, interventional, multicenter study with consecutive enrollment of eligible patients. Each participant will be followed for 3 months, with most activities conducted remotely via the app.
At baseline (T0), patients receive study information, provide consent, undergo training, register in the app, and complete initial assessments (clinical, socio-demographic, PROMIS Global, HADS-A). At 12 weeks (W12), follow-up includes all outcome questionnaires and data on unplanned hospital visits.
The app includes features such as a personal diary (symptoms, weight, BMI, appointments), interactive questionnaires with tailored feedback, and educational content on nutrition, prevention, emotional support, and patient rights.
Population Inclusion criteria: adults (≥18 years) with pancreatic cancer, access to a smartphone/tablet (or caregiver support), ability to consent, and understanding of Italian. Exclusion criteria include severe cognitive impairment, inability to use the app or complete follow-up, or withdrawal of consent.
Sample Size and Analysis A total of 185 patients will be enrolled (accounting for 10% dropout), based on an expected 70% engagement rate. Analyses will be conducted on both intention-to-observe and per-protocol populations. Engagement will be analyzed as questionnaire completion rates, while other outcomes will be analyzed using appropriate statistical models (e.g., logistic regression, ANCOVA, descriptive statistics). An interim analysis at 50% enrollment is planned to address potential low engagement.
- Conditions
- Ductal Adenocarcinoma of Pancreas, Pancreatectomy, Caregiver, Nutritional Evaluation, Post Surgery Patients, Pain Management
- Being tested
- use of PancreasPlus app
- Keywords
- App, Quality of life
- Medical subject headings
- Agnosia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of PancreasPlus appOther
If the participant chooses to take part, they will be asked to use the PancreasPlus app for approximately 3 months. The app is designed to support the care pathway by helping track symptoms, weight, and other health aspects. At the beginning, the participant will receive instructions to download the app and create an account.
The participant will complete short questionnaires on physical and psychological wellbeing, including anxiety levels, quality of life, and satisfaction with the app. They will also access personalized content on symptom management, diet, treatments, and emotional support.
If the app detects warning signs, it will suggest contacting the healthcare team but will not make clinical decisions. All medical decisions remain the responsibility of the treating physicians. Reminder calls may be made during the study.
| Study group | Role | What they receive |
|---|---|---|
| PancreasPlus app | Other | Not described Receives: Other: use of PancreasPlus app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Engagement
Feasibility and engagement will be assessed as a composite indicator of operational sustainability and active participation (co-production) in routine care. This will be operationalized as the proportion of enrolled participants who complete the scheduled questionnaires at Week 12.
Measured: 3 months
Consumer-Perceived Quality of Care (CSQ-8 Score)
Consumer-perceived quality of care will be assessed using the Client Satisfaction Questionnaire (CSQ-8; total score range: 8-32, with higher scores indicating greater satisfaction).
Measured: 3 months
Secondary outcomes (7)
App Usability (System Usability Scale - SUS)
Usability will be assessed using the System Usability Scale (SUS). Higher scores indicate greater usability. The System Usability Scale (SUS) produces a total score ranging from a minimum of 0 to a maximum of 100. These scores represent the percentile rank of a product's perceived usability, not a percentage, with an average score typically hovering around 68.
Minimum Value (0): Represents the lowest perceived usability. Maximum Value (100): Represents the highest perceived usability.
Measured: 3 months
Global Quality of Life (PROMIS Global Health - Global Physical Health [GPH] and Global Mental Health [GMH] scores)
Change in global quality of life will be assessed using the PROMIS Global Health questionnaire (Global Physical Health [GPH] and Global Mental Health [GMH] scores). Outcome is defined as the change in scores from baseline (T0, start of app use) to Week 12. Global Physical and Global Mental Health subscales are computed separately and generally range from roughly 20 to 80 (T-score), where higher scores indicate better health.
Measured: 3 months (Baseline (T0) to Week 12)
Anxiety (HADS-A Score)
Change in anxiety levels will be assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). Outcome is defined as the change in scores from baseline (T0) to Week 12. The Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) consists of 7 items, with total scores ranging from a minimum of 0 to a maximum of 21. Higher scores indicate greater severity, generally interpreted as 0-7 (Normal), 8-10 (Mild/Borderline), 11-14 (Moderate), and 15-21 (Severe).
Measured: 3 months (baseline (T0) to Week 12)
Unscheduled Healthcare Utilization
Number of unscheduled healthcare accesses, including emergency department visits, hospital admissions, and additional unplanned medical visits occurring during the study period.
Measured: From baseline (T0) to 3 months (Week 12)
Chemotherapy Adherence
Adherence to chemotherapy will be assessed in adjuvant, induction, or neoadjuvant settings, including timing relative to surgery (if applicable), number of cycles completed, dose modifications, and treatment interruptions due to adverse events.
Measured: From baseline (T0) to 3 months (Week 12)
Nutritional Status (Weight and Body Mass Index Monitoring)
Nutritional status will be assessed through patient self-monitoring of body weight and calculation of Body Mass Index (BMI). Outcome includes changes in weight and BMI over time.
Measured: Baseline (T0) to 3 months (Week 12)
App Acceptability (Unified Theory of Acceptance and Use of Technology -UTAUT2)
Acceptability will be evaluated using the short version of the Unified Theory of Acceptance and Use of Technology (UTAUT2) questionnaire. Higher scores indicate greater acceptability.The most common approach is a 7-point scale, ranging from 1 (Strongly Disagree) to 7 (Strongly Agree)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start26 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Adenocarcinoma of PancreasStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532590
- Sponsor's protocol ID
- 797CET
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Use of an App (PancreasPlus) for Home Monitoring and Proactive Management of Patients With Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT07532590
- Acronym / sponsor ID
- 797CET
- Conditions
- Ductal Adenocarcinoma of Pancreas, Pancreatectomy, Caregiver, Nutritional Evaluation, Post Surgery Patients, Pain Management
- Keywords
- App, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Apr 2026 (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.
Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. However, this active involvement can be difficult if there is poor communication with healthcare teams, differences in skills or familiarity with digital tools, or systems that do not support patient participation.
The PancreasPlus app was developed to support patients and caregivers by providing reliable information, self-monitoring tools, and a communication channel with healthcare professionals. The study aims to assess the feasibility, patient engagement, and perceived quality of routine use of the app. It is hypothesized that its use will improve engagement, perceived quality, reduce anxiety and unplanned hospital visits, without introducing technological or privacy risks. The app supports information and data collection but does not replace clinical decision-making.
Objectives
Primary objectives:
Assess feasibility and patient engagement through questionnaire completion. Evaluate perceived service quality using the Client Satisfaction Questionnaire (CSQ-8).
Secondary objectives:
Monitor unplanned hospital visits and adherence to chemotherapy. Assess anxiety (HADS-A), nutritional status, and global quality of life (PROMIS Global).
Evaluate usability and acceptability of the app (SUS, UTAUT2 short version).
Endpoints Primary endpoints include questionnaire completion rates and perceived quality (CSQ-8 score). Secondary endpoints include unplanned hospital access, chemotherapy adherence, anxiety levels, nutritional status, quality of life, and app usability/acceptability.
Methods This is a prospective, interventional, multicenter study with consecutive enrollment of eligible patients. Each participant will be followed for 3 months, with most activities conducted remotely via the app.
At baseline (T0), patients receive study information, provide consent, undergo training, register in the app, and complete initial assessments (clinical, socio-demographic, PROMIS Global, HADS-A). At 12 weeks (W12), follow-up includes all outcome questionnaires and data on unplanned hospital visits.
The app includes features such as a personal diary (symptoms, weight, BMI, appointments), interactive questionnaires with tailored feedback, and educational content on nutrition, prevention, emotional support, and patient rights.
Population Inclusion criteria: adults (≥18 years) with pancreatic cancer, access to a smartphone/tablet (or caregiver support), ability to consent, and understanding of Italian. Exclusion criteria include severe cognitive impairment, inability to use the app or complete follow-up, or withdrawal of consent.
Sample Size and Analysis A total of 185 patients will be enrolled (accounting for 10% dropout), based on an expected 70% engagement rate. Analyses will be conducted on both intention-to-observe and per-protocol populations. Engagement will be analyzed as questionnaire completion rates, while other outcomes will be analyzed using appropriate statistical models (e.g., logistic regression, ANCOVA, descriptive statistics). An interim analysis at 50% enrollment is planned to address potential low engagement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PancreasPlus app | Other | Other: use of PancreasPlus app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18; diagnosis of pancreatic cancer (histological/cytological)
- Access to a smartphone or tablet and a data connection; basic digital literacy or a caregiver available,
- Ability to understand and provide informed consent; understanding of the Italian language.
Key exclusion criteria (3 listed)
- Severe uncompensated cognitive impairment,
- Social or logistical circumstances that prevent follow-up or access to/use of the app,
- Refusal or withdrawal of consent.
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 |
|---|---|---|
| use of PancreasPlus appIf the participant chooses to take part, they will be asked to use the PancreasPlus app for approximately 3 months. The app is designed to support the care pathway by helping track symptoms, weight, and other health aspects. At the beginning, the participant will receive instructions to download the app and create an account. The participant will complete short questionnaires on physical and psychological wellbeing, including anxiety levels, quality of life, and satisfaction with the app. They will also access personalized content on symptom management, diet, treatments, and emotional support. If the app detects warning signs, it will suggest contacting the healthcare team but will not make clinical decisions. All medical decisions remain the responsibility of the treating physicians. Reminder calls may be made during the study. | Other | PancreasPlus app |
Primary outcome
Feasibility and Engagement
Time frame: 3 months
Feasibility and engagement will be assessed as a composite indicator of operational sustainability and active participation (co-production) in routine care. This will be operationalized as the proportion of enrolled participants who complete the scheduled questionnaires at Week 12.
Consumer-Perceived Quality of Care (CSQ-8 Score)
Time frame: 3 months
Consumer-perceived quality of care will be assessed using the Client Satisfaction Questionnaire (CSQ-8; total score range: 8-32, with higher scores indicating greater satisfaction).
7 secondary outcomes
App Usability (System Usability Scale - SUS)
Time frame: 3 months
Global Quality of Life (PROMIS Global Health - Global Physical Health [GPH] and Global Mental Health [GMH] scores)
Time frame: 3 months (Baseline (T0) to Week 12)
Anxiety (HADS-A Score)
Time frame: 3 months (baseline (T0) to Week 12)
Unscheduled Healthcare Utilization
Time frame: From baseline (T0) to 3 months (Week 12)
Chemotherapy Adherence
Time frame: From baseline (T0) to 3 months (Week 12)
Nutritional Status (Weight and Body Mass Index Monitoring)
Time frame: Baseline (T0) to 3 months (Week 12)
App Acceptability (Unified Theory of Acceptance and Use of Technology -UTAUT2)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of PancreasPlus app in people with Ductal Adenocarcinoma of Pancreas and Pancreatectomy, run by Casa di Cura Dott. Pederzoli at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Engagement (time frame: 3 months). The study lists 2 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 11 May 2026; AzTrials last refreshed its copy on 9 Nov 2026.