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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Quality of Life; Esophageal Cancer (EsC); Sarcopenia

Treatments: Behavioral: symptom management health informatics plus Resistance band exercise training; Behavioral: Usual Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07180134

202302087B0

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care Group

Symptom Management Health Informatics plus Resistance Exercise Group

Experimental group

Description:

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

Treatment:

Behavioral: symptom management health informatics plus Resistance band exercise training