REcovery After Cancer Application

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • The RECapp platform

    Device

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
13 weeks after hospital discharge

Secondary outcomes

1

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.

Time frame
26 weeks after hospital discharge
2

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.

Time frame
26 weeks after hospital discharge
3

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.

Time frame
26 weeks after hospital discharge
4

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.

Time frame
26 weeks after hospital discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska Trial Alliance

Collaborator

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