Набор скоро начнётся NCT07642492

REcovery After Cancer Application

Без фазы С лечением Oesophageal Cancer Gastric Cancer (Diagnosis)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: The RECapp platform.
Кому может быть актуально: Состояния в реестре: Oesophageal Cancer, Gastric Cancer (Diagnosis). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

REcovery After Cancer Application (RECapp) - Personalised Support After Surgery for Oesophageal and Gastric Cancer Patients

Обзор

The RECapp study is a clinical trial evaluating a digital tool designed to support patients recovering from surgery for oesophageal or stomach cancer. The goal is to reduce symptoms and improve quality of life during recovery. Each year in Sweden, around 1,400 people are diagnosed with these cancers. Although more people are surviving thanks to better treatments, recovery after surgery is often long and challenging, with lasting physical and emotional effects. At the same time, healthcare systems are under pressure to provide long-term support. RECapp is a digital platform developed together with patients and healthcare professionals. It includes a mobile app for patients and a web portal for healthcare staff. Patients can track their symptoms, receive personalised self-care advice, and get guidance on when to contact healthcare. Healthcare providers can follow patients' progress remotely. In this study, 250 patients from across Sweden will take part. They will be randomly assigned to either standard care or standard care plus RECapp. Participants will be followed for six months after surgery, and their symptoms and quality of life will be regularly assessed through questionnaires. If RECapp proves effective, it could become part of future cancer care in Sweden-helping patients feel better supported while also making care more efficient.

Подробное описание

The overall aim of the clinical trial is to evaluate the digital RECapp-platform, intended to reduce symptom burden and improve quality of life for patients who have undergone surgery with curative intent for oesophageal or gastric cancer.

In Sweden, approximately 1,400 patients, predominantly older men, are diagnosed with oesophageal or gastric cancer each year. Despite the poor prognosis of these cancer diagnoses, the number of survivors is increasing due to improved treatment options. When a curative approach is pursued, extensive, resectional surgery is usually performed, often in combination with oncological treatment. After surgery, recovery can be long, difficult, and incomplete, with reduced quality of life on a physical, psychological, and social level.

Cancer care providers and healthcare systems are challenged in meeting the growing needs of the rising number of patients surviving cancer. Furthermore, traditional long-term follow-up care involving routine hospital visits is being questioned for its effectiveness and the anxiety it may cause. There is a growing interest in patient-initiated and technology-assisted follow-ups using mobile applications to enhance autonomy, improve recovery, and reduce pressure on healthcare systems.

The Surgical Care Science research group has through multiprofessional collaborations and patient involvement developed the RECapp platform, consisting of a mobile app for patients and a web-based care portal for healthcare providers. The platform helps patients self-monitor their symptoms, provides personalised feedback, and recommends actions based on the symptoms reported. The RECapp platform allows patients to access their data through the RECapp app, while healthcare providers can review patient data in the RECapp care portal. The ambition has been to develop a digital platform to reduce symptom burden and increase patient autonomy in managing symptoms during the post-surgery recovery process, but also improve communication between patients and healthcare providers and optimise healthcare resource use by minimising unnecessary appointments and contacts.

The trial aims to test the RECapp-platform in a national randomised controlled trial, where 250 patients will be randomly assigned to either an intervention group (standard care + RECapp) or a control group (standard care only). Each research participant will be included in the study prior to surgery, and followed up for six months from hospital discharge post-surgery when the intervention is initiated. Both groups will be regularly assessed through validated questionnaires. The primary outcome is symptom burden at three months, and several secondary outcomes will be assessed at both three and six months. Sweden's seven university hospitals will be invited to participate in the clinical trial. Close relatives will be invited through participating patients, to respond to questionnaires about their experience as a close relative to these patients.

If the RECapp platform is shown to have positive effects on patients' symptom burden and thus their health-related quality of life, an implementation of the platform into Swedish cancer care will be considered. The RECapp platform can play a future role in Swedish cancer care, not only to enhance life for cancer survivors and their relatives but also to achieve health economic benefits.

Вмешательства

Устройство The RECapp platform
The RECapp platform is a device for oesophageal and gastric cancer patients having undergone invasive surgery as part of the curatively intended treatment regime. It is designed to improve recovery and mitigate symptom burden. The RECapp platform includes a mobile application to be used by patients, the RECapp app, and a web application system to be used by healthcare providers, the RECapp care portal. The RECapp app tracks symptom burden through questionnaires, provides feedback on individual s

Первичные конечные точки

Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge [Срок оценки: 13 weeks after hospital discharge]

Вторичные конечные точки (9)

Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean EORTC QLQ-OG25 overall symptom summary score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean Memorial Symptom Assessment Scale (MSAS) physical symptom distress score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean Memorial Symptom Assessment Scale (MSAS) psychological symptom distress score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean Memorial Symptom Assessment Scale (MSAS) global distress index score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean Strategies Used by People to Promote Health (SUPPH-29) self-efficacy score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean HLS19-Q12 general health literacy score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]
Mean Assessment of Survivor Concerns (ASC) overall score at 26 weeks after hospital discharge [Срок оценки: 26 weeks after hospital discharge]

Критерии участия

Критерии включения

Patients who have undergone invasive surgery with curative intent for oesophageal or gastric cancer (including salvage surgery)
≥18 years of age
Ability to read, understand, and complete study materials in Swedish, including consent forms, questionnaires, and instructions
Access to a smartphone or tablet with personal BankID