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REcovery After Cancer Application (RECapp)

7 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svezia
      • Gothenburg, Svezia
        • Sahlgrenska University Hospital
        • Contatto:
        • Investigatore principale:
          • Christina Biörserud
      • Linköping, Svezia
        • Linköping University Hospital
        • Contatto:
        • Investigatore principale:
          • David Edholm
      • Lund, Svezia
        • Skåne University Hospital
        • Contatto:
        • Investigatore principale:
          • Jan Johansson
      • Stockholm, Svezia
        • Karolinska University Hospital
        • Contatto:
        • Investigatore principale:
          • Berit Sunde
      • Umeå, Svezia
      • Uppsala, Svezia
        • Uppsala University Hospital
        • Contatto:
        • Investigatore principale:
          • Jakob Hedberg
      • Örebro, Svezia
        • Örebro University Hospital
        • Contatto:
        • Investigatore principale:
          • Eva Szabo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention arm
Standard care after surgery for oesophageal and gastric cancer + RECapp
Dispositivo: 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.
Altro: Control arm
Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Karolinska Institutet

Collaboratori

Karolinska Trial Alliance

Investigatori

  • Direttore dello studio: Pernilla Lagergren, Professor, Surgical care science, Molecular Medicine and Surgery, Karolinska Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

15 dicembre 2029

Completamento dello studio (Stimato)

15 dicembre 2029

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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