이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

REcovery After Cancer Application (RECapp)

2026년 6월 7일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

250

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 스웨덴
      • Gothenburg, 스웨덴
        • Sahlgrenska University Hospital
        • 연락하다:
        • 수석 연구원:
          • Christina Biörserud
      • Linköping, 스웨덴
      • Lund, 스웨덴
        • Skåne University Hospital
        • 연락하다:
        • 수석 연구원:
          • Jan Johansson
      • Stockholm, 스웨덴
        • Karolinska University Hospital
        • 연락하다:
        • 수석 연구원:
          • Berit Sunde
      • Umeå, 스웨덴
      • Uppsala, 스웨덴
        • Uppsala University Hospital
        • 연락하다:
        • 수석 연구원:
          • Jakob Hedberg
      • Örebro, 스웨덴
        • Örebro University Hospital
        • 연락하다:
        • 수석 연구원:
          • Eva Szabo

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention arm
Standard care after surgery for oesophageal and gastric cancer + RECapp
장치: 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.
다른: Control arm
Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Karolinska Institutet

협력자

Karolinska Trial Alliance

수사관

  • 연구 책임자: Pernilla Lagergren, Professor, Surgical care science, Molecular Medicine and Surgery, Karolinska Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2029년 12월 15일

연구 완료 (추정된)

2029년 12월 15일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 6월 7일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 7일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RECapp study
  • VR-2023-02178 (기타 보조금/기금 번호: The Swedish Research Council)
  • CF-23 3208 S 01 H (기타 보조금/기금 번호: The Swedish Cancer Society)
  • SS-2024-01-04:06 (기타 보조금/기금 번호: The Sjöberg Foundation)
  • RS 2024-0781 (기타 보조금/기금 번호: Swedish governmental funding of clinical research (ALF))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

식도암에 대한 임상 시험

The RECapp platform에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Malta

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다