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REcovery After Cancer Application (RECapp)

7. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Gerät: The RECapp platform

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

250

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Pernilla Lagergren, Professor
Telefonnummer: +46852482758
E-Mail: pernilla.lagergren@ki.se

Studieren Sie die Kontaktsicherung

Name: Marta Lason
Telefonnummer: +46852485397
E-Mail: marta.lason@ki.se

Studienorte

Schweden
- - Gothenburg, Schweden
    - Sahlgrenska University Hospital
    - Kontakt:
      
      Christina Biörserud
      
      Telefonnummer: +4631-342 84 04
      
      E-Mail: christina.biorserud@vrgregion.se
    - Hauptermittler:
      
      Christina Biörserud
  - Linköping, Schweden
    - Linköping University Hospital
    - Kontakt:
      
      David Edholm
      
      Telefonnummer: +4672-923 78 66
      
      E-Mail: david.edholm@regionostergotland.se
    - Hauptermittler:
      
      David Edholm
  - Lund, Schweden
    - Skåne University Hospital
    - Kontakt:
      
      Jan Johansson
      
      Telefonnummer: +4646-17 14 32
      
      E-Mail: jan.johansson@skane.se
    - Hauptermittler:
      
      Jan Johansson
  - Stockholm, Schweden
    - Karolinska University Hospital
    - Kontakt:
      
      Berit Sunde
      
      Telefonnummer: +468-123 86 721
      
      E-Mail: berit.sunde@ki.se
    - Hauptermittler:
      
      Berit Sunde
  - Umeå, Schweden
    - University Hospital of Umeå
    - Kontakt:
      
      Andrianos Tsekrekos
      
      Telefonnummer: +4676-206 32 58
      
      E-Mail: andrianos.tsekrekos@regionvasterbotten.se
    - Hauptermittler:
      
      Andrianos Tsekrekos
  - Uppsala, Schweden
    - Uppsala University Hospital
    - Kontakt:
      
      Jakob Hedberg
      
      Telefonnummer: +4670-378 59 73
      
      E-Mail: jakob.hedberg@uu.se
    - Hauptermittler:
      
      Jakob Hedberg
  - Örebro, Schweden
    - Örebro University Hospital
    - Kontakt:
      
      Eva Szabo
      
      Telefonnummer: +4619-602 10 00
      
      E-Mail: eva.szabo@regionorebrolan.se
    - Hauptermittler:
      
      Eva Szabo

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Unterstützende Pflege
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: Intervention arm Standard care after surgery for oesophageal and gastric cancer + RECapp	Gerät: 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.
Sonstiges: Control arm Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.	Gerät: 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.

Teilnehmergruppe / Arm

Intervention / Behandlung

Experimental: Intervention arm

Standard care after surgery for oesophageal and gastric cancer + RECapp

Gerät: 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.

Sonstiges: Control arm

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

Gerät: The RECapp platform

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karolinska Institutet

Mitarbeiter

Karolinska Trial Alliance

Ermittler

Studienleiter: Pernilla Lagergren, Professor, Surgical care science, Molecular Medicine and Surgery, Karolinska Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

RECapp's official webpage

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

15. Dezember 2029

Studienabschluss (Geschätzt)

15. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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