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

NCT ID: NCT07180134

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer (EsC) Sarcopenia Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care Group

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

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

symptom management health informatics plus Resistance band exercise training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Ling Chang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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YULING CHANG

Role: CONTACT

886+966572613

References

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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.

Reference Type BACKGROUND
PMID: 26238649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23357884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31670173 (View on PubMed)

Related Links

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https://www.cgu.edu.tw/

Chang Gung University

Other Identifiers

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202302087B0

Identifier Type: -

Identifier Source: org_study_id

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