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Not yet recruitingNCT07180134Updated Sep 18, 2025

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

An interventional study of symptom management health informatics plus Resistance band exercise training and Usual Care Group in Esophageal Cancer (EsC), Sarcopenia and Quality of Life, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Esophageal Cancer (EsC)
  • Sarcopenia
  • Quality of Life

Keywords

  • Esophagectomy
  • Nutrition
  • Quality of life
  • Exercise
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 90 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Usual Care Group

    Participants receive standard postoperative nursing care and education as routinely provided by the clinical team. No additional interventions will be given.

    Behavioral: Usual Care Group

  • Experimental
    Symptom Management Health Informatics plus Resistance Exercise Group

    Participants receive access to a symptom management health informatics program and a structured resistance band exercise training program.

    Behavioral: symptom management health informatics plus Resistance band exercise training

Interventions

  • Behavioralsymptom management health informatics plus Resistance band exercise training

    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.

  • BehavioralUsual Care Group

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

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Chang YL, Tsai YF, Chao YK, Wu MY. Quality-of-life measures as predictors of post-esophagectomy survival of patients with esophageal cancer. Qual Life Res. 2016 Feb;25(2):465-475. doi: 10.1007/s11136-015-1094-4. Epub 2015 Aug 4. PubMed 26238649 ↗
  • Chang YL, Tsai YF, Wu YC, Hsieh MJ. Factors relating to quality of life after esophagectomy for cancer patients in Taiwan. Cancer Nurs. 2014 Jan-Feb;37(1):4-13. doi: 10.1097/NCC.0b013e318277dc53. PubMed 23357884 ↗
  • Chang YL, Tsai YF, Hsu CL, Chao YK, Hsu CC, Lin KC. The effectiveness of a nurse-led exercise and health education informatics program on exercise capacity and quality of life among cancer survivors after esophagectomy: A randomized controlled trial. Int J Nurs Stud. 2020 Jan;101:103418. doi: 10.1016/j.ijnurstu.2019.103418. Epub 2019 Sep 11. PubMed 31670173 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07180134
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Yu-Ling Chang (Assistant Professor, Chang Gung University) — Principal investigator
First posted
Sep 18, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 18, 2025

Study contacts

YULING CHANG
Contact
witchchange@gmail.com
886+966572613

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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