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).

Официальное название

A Prospective Study on the Use of an App (PancreasPlus) for Home Monitoring and Proactive Management of Patients With Pancreatic Cancer.

Обзор

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.

Вмешательства

• Другое use 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

Первичные конечные точки

• Feasibility and Engagement [Срок оценки: 3 months]
• Consumer-Perceived Quality of Care (CSQ-8 Score) [Срок оценки: 3 months]

Вторичные конечные точки (7)

• App Usability (System Usability Scale - SUS) [Срок оценки: 3 months]
• Global Quality of Life (PROMIS Global Health - Global Physical Health [GPH] and Global Mental Health [GMH] scores) [Срок оценки: 3 months (Baseline (T0) to Week 12)]
• Anxiety (HADS-A Score) [Срок оценки: 3 months (baseline (T0) to Week 12)]
• Unscheduled Healthcare Utilization [Срок оценки: From baseline (T0) to 3 months (Week 12)]
• Chemotherapy Adherence [Срок оценки: From baseline (T0) to 3 months (Week 12)]
• Nutritional Status (Weight and Body Mass Index Monitoring) [Срок оценки: Baseline (T0) to 3 months (Week 12)]
• App Acceptability (Unified Theory of Acceptance and Use of Technology -UTAUT2) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Severe uncompensated cognitive impairment,
• Social or logistical circumstances that prevent follow-up or access to/use of the app,
• Refusal or withdrawal of consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 2 центра

• U.O. Chirurgia Generale 1, IRCCS San Matteo, Università degli Studi di Pavia — Pavia
• Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Идентификаторы

NCT: NCT07532590 · 797CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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