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

NCT07180134 | Not Yet Recruiting

• 1 other identifier: 202302087B0
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Esophageal Cancer (EsC); Sarcopenia; Quality of Life

Keywords

Esophagectomy; Nutrition; Quality of life; Exercise

Outcome Measures

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.

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

Secondary Outcomes (3)

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

  1 month, 3 months, 6 months after intervention

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

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

• Body Mass Index (BMI)

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

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

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

Symptom Management Health Informatics plus Resistance Exercise Group

EXPERIMENTAL

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

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.

Symptom Management Health Informatics plus Resistance Exercise Group

Usual Care Group BEHAVIORAL

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

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (3)

• 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.

  PMID: 26238649 BACKGROUND

• 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.

  PMID: 23357884 BACKGROUND

• 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.

  PMID: 31670173 BACKGROUND

Related Links

• Chang Gung University

MeSH Terms

Conditions

Esophageal Neoplasms; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Central Study Contacts

YULING CHANG

CONTACT

886+966572613; witchchange@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: the experimental group also received a 12-week intervention consisting of "symptom management health informatics" and "home-based resistance exercise with elastic bands." The health informatics component included educational videos and an instant communication platform addressing common postoperative gastrointestinal symptoms, their mechanisms, and management strategies, such as reflux, dysphagia, dumping syndrome, and delayed gastric emptying. The communication platform enabled two-way interaction, allowing patients to raise concerns and health providers to respond promptly. The resistance exercise program included instructional videos and individualized exercise prescriptions taught before discharge. Patients were instructed to perform band-based resistance exercises at home, avoiding practice within one hour after meals. Each session lasted 40-60 minutes, including warm-up, resistance, and cool-down, performed three times per week for 12 weeks.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share