Caregiver, Ductal Adenocarcinoma of Pancreas, Nutritional Evaluation, Pain Management, Pancreatectomy, Post Surgery Patients
Conditions
Keywords
App, Quality of life
Brief 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. 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.
Interventions
OTHERuse of PancreasPlus app
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.
Sponsors
Casa di Cura Dott. Pederzoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Severe uncompensated cognitive impairment, * Social or logistical circumstances that prevent follow-up or access to/use of the app, * Refusal or withdrawal of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Engagement | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App Usability (System Usability Scale - SUS) | 3 months | 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. |
| Global Quality of Life (PROMIS Global Health - Global Physical Health [GPH] and Global Mental Health [GMH] scores) | 3 months (Baseline (T0) to Week 12) | 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. |
| Anxiety (HADS-A Score) | 3 months (baseline (T0) to Week 12) | 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). |
| Unscheduled Healthcare Utilization | From baseline (T0) to 3 months (Week 12) | Number of unscheduled healthcare accesses, including emergency department visits, hospital admissions, and additional unplanned medical visits occurring during the study period. |
| Chemotherapy Adherence | From baseline (T0) to 3 months (Week 12) | 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. |
| Nutritional Status (Weight and Body Mass Index Monitoring) | Baseline (T0) to 3 months (Week 12) | 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. |
| App Acceptability (Unified Theory of Acceptance and Use of Technology -UTAUT2) | 3 months | 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) |
Countries
Italy
Outcome results
None listed