Esophageal Cancer (EsC)NCT07180134
Health Informatics and Resistance Exercise for Symptom Management and Quality of Life in Post-Esophagectomy Patients
A study testing symptom management health informatics plus Resistance band exercise training in people with Esophageal Cancer (EsC) and Sarcopenia, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer (EsC), Sarcopenia, Quality of Life
- What is being tested?
- symptom management health informatics plus Resistance band exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- symptom management health informatics plus Resistance band exercise training, Usual Care Group
- Keywords
- Esophagectomy, Nutrition, Quality of life, Exercise
- Medical subject headings
- Esophageal Neoplasms, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom management health informatics plus Resistance band exercise trainingBehavioural
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.
Usual Care GroupBehavioural
Standard postoperative nursing care and education routinely provided by the clinical team. No additional interventions will be given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: symptom management health informatics plus Resistance band exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, 6 months after intervention
Secondary outcomes (3)
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.
Measured: 1 month, 3 months, 6 months after intervention
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.
Measured: Baseline, 1 month, 3 months, 6 months after intervention
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.
Measured: Baseline, 1 month, 3 months, 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Cancer (EsC)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ling Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180134
- Sponsor's protocol ID
- 202302087B0
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26238649Chang 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 23357884Chang 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07180134
- Acronym / sponsor ID
- 202302087B0
- Conditions
- Esophageal Cancer (EsC), Sarcopenia, Quality of Life
- Keywords
- Esophagectomy, Nutrition, Quality of life, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Behavioral: Usual Care GroupParticipants receive standard postoperative nursing care and education as routinely provided by the clinical team. No additional interventions will be given. |
| Symptom Management Health Informatics plus Resistance Exercise Group | Experimental | Behavioral: symptom management health informatics plus Resistance band exercise trainingParticipants receive access to a symptom management health informatics program and a structured resistance band exercise training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| symptom management health informatics plus Resistance band exercise trainingAccess 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. | Behavioural | Symptom Management Health Informatics plus Resistance Exercise Group |
| Usual Care GroupStandard postoperative nursing care and education routinely provided by the clinical team. No additional interventions will be given. | Behavioural | Usual Care Group |
Primary outcome
Quality of Life (EORTC QLQ-C30 score)
Time frame: Baseline, 1 month, 3 months, 6 months after intervention
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 26238649Chang 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.
- Results publication: PubMed 23357884Chang 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.
- Results publication: PubMed 31670173Chang 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.
- Chang Gung UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing symptom management health informatics plus Resistance band exercise training in people with Esophageal Cancer (EsC) and Sarcopenia, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YULING CHANG (886+966572613, witchchange@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EORTC QLQ-C30 score) (time frame: Baseline, 1 month, 3 months, 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180134, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.