About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
The RECapp platform
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 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.
Secondary outcomes
Mean EORTC QLQ-C30 Summary Score at 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.
Mean EORTC QLQ-OG25 overall symptom summary score at 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.
Mean modified Memorial Symptom Assessment Scale (MSAS) total score at 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.
Mean Memorial Symptom Assessment Scale (MSAS) physical symptom distress score at 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.
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Karolinska Trial Alliance
Collaborator
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