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NCT Number: NCT07180134

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • With or without adjuvant chemoradiotherapy
  • Clear consciousness and able to communicate in Mandarin or Taiwanese

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Quality of Life (EORTC QLQ-C30 score)

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Body Mass Index (BMI)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

YULING CHANG

CONTACT

[email protected]

886+966572613

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effects of Health Informatics for Symptom Management and Resistance Exercise Strategies on Quality of Life and Sarcopenia in Post-Esophagectomy Patients With Esophageal Cancer: A Mixed-Methods Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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