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Not yet recruiting NCT07180134

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

No phase Interventional Esophageal Cancer (EsC) Sarcopenia Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: symptom management health informatics plus Resistance band exercise training, Usual Care Group.
Who it may be relevant to
Registry conditions: Esophageal Cancer (EsC), Sarcopenia, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Behavioral symptom 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.
  • Behavioral Usual Care Group
    Standard postoperative nursing care and education routinely provided by the clinical team. No additional interventions will be given.

Primary outcome measures

  • Quality of Life (EORTC QLQ-C30 score) [Time frame: Baseline, 1 month, 3 months, 6 months after intervention]
Secondary outcome measures (3)
  • Esophageal Cancer-related Symptoms (EORTC QLQ-OES18 score) [Time frame: 1 month, 3 months, 6 months after intervention]
  • Sarcopenia Status (e.g., SARC-F or handgrip strength, muscle mass index) [Time frame: Baseline, 1 month, 3 months, 6 months after intervention]
  • Body Mass Index (BMI) [Time frame: Baseline, 1 month, 3 months, 6 months after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 31670173

Identifiers

NCT: NCT07180134 · 202302087B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗