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临床试验/NCT07642492
NCT07642492尚未招募不适用

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

Karolinska Institutet7 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年9月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
7

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - Cognitive impairment

研究组 & 干预措施

Intervention arm

Experimental

Standard care after surgery for oesophageal and gastric cancer + RECapp

干预措施: The RECapp platform (Device)

Control arm

Other

Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.

干预措施: The RECapp platform (Device)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernilla Lagergren

Professor

Karolinska Institutet

研究点 (7)

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