NCT07532590 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.
| NCT ID | NCT07532590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Casa di Cura Dott. Pederzoli |
| Condition | Ductal Adenocarcinoma of Pancreas |
| Study Type | INTERVENTIONAL |
| Enrollment | 185 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2027-03 |
Trial Parameters
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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.
Eligibility Criteria
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.