REcovery After Cancer Application (RECapp)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pernilla Lagergren, Professor
- 電話番号：+46852482758
- メール：pernilla.lagergren@ki.se
研究連絡先のバックアップ
- 名前：Marta Lason
- 電話番号：+46852485397
- メール：marta.lason@ki.se
研究場所
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Gothenburg、スウェーデン
- Sahlgrenska University Hospital
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コンタクト：
- Christina Biörserud
- 電話番号：+4631-342 84 04
- メール：christina.biorserud@vrgregion.se
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主任研究者：
- Christina Biörserud
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Linköping、スウェーデン
- Linköping University Hospital
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コンタクト：
- David Edholm
- 電話番号：+4672-923 78 66
- メール：david.edholm@regionostergotland.se
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主任研究者：
- David Edholm
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Lund、スウェーデン
- Skane University Hospital
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コンタクト：
- Jan Johansson
- 電話番号：+4646-17 14 32
- メール：jan.johansson@skane.se
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主任研究者：
- Jan Johansson
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Stockholm、スウェーデン
- Karolinska University Hospital
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コンタクト：
- Berit Sunde
- 電話番号：+468-123 86 721
- メール：berit.sunde@ki.se
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主任研究者：
- Berit Sunde
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Umeå、スウェーデン
- University Hospital of Umeå
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コンタクト：
- Andrianos Tsekrekos
- 電話番号：+4676-206 32 58
- メール：andrianos.tsekrekos@regionvasterbotten.se
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主任研究者：
- Andrianos Tsekrekos
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Uppsala、スウェーデン
- Uppsala University Hospital
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コンタクト：
- Jakob Hedberg
- 電話番号：+4670-378 59 73
- メール：jakob.hedberg@uu.se
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主任研究者：
- Jakob Hedberg
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Örebro、スウェーデン
- Örebro University Hospital
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コンタクト：
- Eva Szabo
- 電話番号：+4619-602 10 00
- メール：eva.szabo@regionorebrolan.se
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主任研究者：
- Eva Szabo
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention arm
Standard care after surgery for oesophageal and gastric cancer + RECapp
|
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.
|
|
他の：Control arm
Standard care after surgery for oesophageal and gastric cancer for 6 months, thereafter RECapp in addition to standard care for 6 months.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 13 weeks after hospital discharge
時間枠：13 weeks after hospital discharge
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean EORTC QLQ-C30 Summary Score at 26 weeks after hospital discharge
時間枠：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.
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26 weeks after hospital discharge
|
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Mean EORTC QLQ-OG25 overall symptom summary score at 26 weeks after hospital discharge
時間枠：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.
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26 weeks after hospital discharge
|
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Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 26 weeks after hospital discharge
時間枠：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
時間枠：26 weeks after hospital discharge
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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.
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26 weeks after hospital discharge
|
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Mean Memorial Symptom Assessment Scale (MSAS) psychological symptom distress score at 26 weeks after hospital discharge
時間枠：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
|
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Mean Memorial Symptom Assessment Scale (MSAS) global distress index score at 26 weeks after hospital discharge
時間枠：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
時間枠：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
時間枠：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
|
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Mean Assessment of Survivor Concerns (ASC) overall score at 26 weeks after hospital discharge
時間枠：26 weeks after hospital discharge
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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.
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26 weeks after hospital discharge
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pernilla Lagergren, Professor、Surgical care science, Molecular Medicine and Surgery, Karolinska Institute
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RECapp study
- VR-2023-02178 (その他の助成金/資金番号：The Swedish Research Council)
- CF-23 3208 S 01 H (その他の助成金/資金番号：The Swedish Cancer Society)
- SS-2024-01-04:06 (その他の助成金/資金番号：The Sjöberg Foundation)
- RS 2024-0781 (その他の助成金/資金番号：Swedish governmental funding of clinical research (ALF))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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