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REcovery After Cancer Application (RECapp)

2026年8月4日 更新者：Pernilla Lagergren、Karolinska Institutet

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞典
      • Gothenburg、瑞典
        • Sahlgrenska University Hospital
        • 接触：
        • 首席研究员：
          • Christina Biörserud
      • Linköping、瑞典
      • Lund、瑞典
        • Skane University Hospital
        • 接触：
        • 首席研究员：
          • Jan Johansson
      • Stockholm、瑞典
        • Karolinska University Hospital
        • 接触：
        • 首席研究员：
          • Berit Sunde
      • Umeå、瑞典
      • Uppsala、瑞典
        • Uppsala University Hospital
        • 接触：
        • 首席研究员：
          • Jakob Hedberg
      • Örebro、瑞典
        • Örebro University Hospital
        • 接触：
        • 首席研究员：
          • Eva Szabo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria

  • 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

Exclusion Criteria

- Cognitive impairment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention arm
Standard care after surgery for oesophageal and gastric cancer + RECapp
设备：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 status, and provides self-care advice or alerts patients to contact healthcare based on self-reported symptom burden. The RECapp care portal provides healthcare providers with access to the patients' reported history. The RECapp app is to be used by the patient at home, and the RECapp care portal is to be used by healthcare providers in a healthcare setting.
其他：Control arm
Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.
设备：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 status, and provides self-care advice or alerts patients to contact healthcare based on self-reported symptom burden. The RECapp care portal provides healthcare providers with access to the patients' reported history. The RECapp app is to be used by the patient at home, and the RECapp care portal is to be used by healthcare providers in a healthcare setting.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge
大体时间：13 weeks after hospital discharge
The modified Memorial Symptom Assessment Scale (MSAS) assesses overall symptom burden. The total score is calculated as the mean of item responses and ranges from 0 to 4, with higher scores indicating greater symptom burden.
13 weeks after hospital discharge

次要结果测量

结果测量
措施说明
大体时间
Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) Summary Score is calculated from 13 of the 15 QLQ-C30 scales, excluding the global health status and financial difficulties items. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better health-related quality of life.
26 weeks after hospital discharge
Mean EORTC QLQ-OG25 overall symptom summary score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophago-Gastric Module 25 (QLQ-OG25) overall symptom summary score is calculated as the mean of all QLQ-OG25 symptom scales and single items after transformation to a 0-100 scale. Higher scores indicate greater oesophago-gastric symptom burden. This summary score is used to provide a single interpretable measure of overall symptom burden.
26 weeks after hospital discharge
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The modified Memorial Symptom Assessment Scale (MSAS) assesses overall symptom burden. The total score is calculated as the mean of item responses and ranges from 0 to 4, with higher scores indicating greater symptom burden.
26 weeks after hospital discharge
Mean Memorial Symptom Assessment Scale (MSAS) physical symptom distress score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The Memorial Symptom Assessment Scale (MSAS) physical symptom distress score assesses distress related to physical symptoms. Scores range from 0 to 4, with higher scores indicating greater physical symptom distress.
26 weeks after hospital discharge
Mean Memorial Symptom Assessment Scale (MSAS) psychological symptom distress score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The Memorial Symptom Assessment Scale (MSAS) psychological symptom distress score assesses distress related to psychological symptoms. Scores range from 0 to 4, with higher scores indicating greater psychological symptom distress.
26 weeks after hospital discharge
Mean Memorial Symptom Assessment Scale (MSAS) global distress index score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The Memorial Symptom Assessment Scale (MSAS) global distress index assesses overall symptom-related distress. Scores range from 0 to 4, with higher scores indicating greater global symptom distress.
26 weeks after hospital discharge
Mean Strategies Used by People to Promote Health (SUPPH-29) self-efficacy score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The Strategies Used by People to Promote Health 29-item questionnaire (SUPPH-29) assesses self-care self-efficacy. The score is calculated as the mean of 29 items and ranges from 1 to 5, with higher scores indicating greater self-efficacy.
26 weeks after hospital discharge
Mean HLS19-Q12 general health literacy score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The HLS19-Q12 questionnaire assesses general health literacy. Scores are transformed to a 0-100 scale, with higher scores indicating higher health literacy.
26 weeks after hospital discharge
Mean Assessment of Survivor Concerns (ASC) overall score at 26 weeks after hospital discharge
大体时间：26 weeks after hospital discharge
The Assessment of Survivor Concerns (ASC) measures cancer-related and health-related concerns. The overall score is calculated as the mean of five items (excluding the children's health item) and ranges from 1 to 4, with higher scores indicating greater survivor concerns.
26 weeks after hospital discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karolinska Institutet

合作者

Karolinska Trial Alliance

调查人员

  • 研究主任：Pernilla Lagergren, Professor、Surgical care science, Molecular Medicine and Surgery, Karolinska Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2029年12月15日

研究完成 (估计的)

2029年12月15日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RECapp study
  • VR-2023-02178 (其他赠款/资助编号：The Swedish Research Council)
  • CF-23 3208 S 01 H (其他赠款/资助编号：The Swedish Cancer Society)
  • SS-2024-01-04:06 (其他赠款/资助编号：The Sjöberg Foundation)
  • RS 2024-0781 (其他赠款/资助编号：Swedish governmental funding of clinical research (ALF))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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