Health Informatics and Resistance Exercise for Symptom Management and Quality of Life in Post-Esophagectomy Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

Participants are invited to take part in a research study. In accordance with the requirements of the health authorities, participants must be informed of the purpose of the study and its potential risks. Participation is voluntary, and each participant is free to decide whether or not to enroll. The study may be discussed with trusted individuals, and sufficient time may be taken to consider the decision. If any part of this consent form is unclear, questions may be directed to the principal investigator or the research team, who will provide an explanation.

If a participant chooses not to participate, appropriate treatment will still be provided. Even if a participant agrees to participate initially, withdrawal is allowed at any time without affecting medical rights or the care that should be received.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Diagnosed with esophageal cancer and having undergone esophagectomy

Postoperative pathological report confirms R0 resection (complete tumor removal)

Able to be discharged after surgery

Disqualifiers

Presence of severe cardiovascular disease or psychiatric disorders

Inability to communicate in Mandarin Chinese or Taiwanese

Disease progression during the intervention period that prevents continuation of participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • symptom management health informatics plus Resistance band exercise training

    Behavioral

    Access to educational videos and an instant messaging platform for real-time communication, delivered over 12 weeks. plus Structured resistance band exercise, 3 times per week, \~30 minutes per session, for 12 weeks under research team guidance.

  • Usual Care Group

    Behavioral

    Standard postoperative nursing care and education routinely provided by the clinical team. No additional interventions will be given.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Usual Care GroupActive comparator 1 intervention
Group B: Symptom Management Health Informatics plus Resistance Exercise GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life (EORTC QLQ-C30 score)

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a validated and widely used instrument for assessing quality of life in patients with cancer. It includes five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are linearly transformed to a 0-100 scale; higher scores on functional and global health scales indicate better functioning/quality of life, whereas higher scores on symptom scales indicate greater symptom burden.

Time frame
Baseline, 1 month, 3 months, 6 months after intervention

Secondary outcomes

1

Esophageal Cancer-related Symptoms (EORTC QLQ-OES18 score)

The EORTC QLQ-OES18 is a validated disease-specific module designed to assess esophageal cancer-related symptoms and treatment side effects. It includes 18 items covering dysphagia, eating restrictions, reflux, pain, trouble swallowing saliva, choking when swallowing, dry mouth, taste problems, cough, and speech difficulties. Each item is scored on a 4-point Likert scale and linearly transformed to a 0-100 scale, with higher scores indicating greater symptom burden.

Time frame
1 month, 3 months, 6 months after intervention
2

Sarcopenia Status (e.g., SARC-F or handgrip strength, muscle mass index)

Sarcopenia risk will be assessed using the SARC-F questionnaire, which evaluates strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored 0-2, with a total score ranging from 0 to 10. A score ≥4 indicates risk of sarcopenia.

Time frame
Baseline, 1 month, 3 months, 6 months after intervention
3

Body Mass Index (BMI)

Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight will be measured using a calibrated digital scale, and height will be measured with a stadiometer at baseline. Changes in BMI will be assessed at follow-up visits. Lower BMI values after surgery may indicate postoperative weight loss or malnutrition.

Time frame
Baseline, 1 month, 3 months, 6 months after intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Chang Gung Memorial Hospital

Lead sponsor

Chang Gung University

Sponsor institution

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