- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445243
Integrated Chinese and Western Therapy for Cancer-Related Fatigue
February 28, 2026 updated by: Chia-Ying Chuang, Taichung Tzu Chi Hospital
Clinical Effectiveness Assessment of Integrated Chinese and Western Therapy for Cancer-Related Fatigue
Cancer-related fatigue (CRF) is a common and debilitating symptom in patients with cancer.
Evidence-based non-pharmacological approaches include sleep hygiene, physical activity, nutritional management, and traditional Chinese medicine (TCM).
This study evaluates the clinical effectiveness of an interdisciplinary holistic program integrating Chinese and Western therapies for CRF among hospitalized cancer patients receiving integrated care.
Approximately 100 participants will be enrolled and followed for up to 3 months.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Eligible hospitalized cancer patients receiving integrated Chinese and Western care will be enrolled after providing informed consent.
Participants will complete a CRF questionnaire and receive a non-invasive holistic integrative care program, including patient education, sleep hygiene, exercise guidance, nutritional assessment/intervention, and TCM-related care.
The primary endpoint is change in CRF score.
Secondary endpoints include TCM constitution assessment, vital signs, anthropometrics, complete blood count, and liver/renal function tests.
Participants will be followed for 3 months from enrollment.
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 42743
- Taichung Tzu Chi Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Inclusion Criteria:
Signed informed consent form.
Age 20 to 95 years.
Receiving integrated Chinese and Western holistic care.
Agree to provide clinically relevant data for this study.
Exclusion Criteria:
Refuse to continue participation during the study period, or the family requests discontinuation (withdrawal).
Psychiatric disorder that makes the participant unable to cooperate.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Chinese and Western Holistic Care
All participants receive an integrated Chinese and Western holistic care program during hospitalization for cancer-related fatigue management.
The program includes routine fatigue assessment and individualized supportive care measures (education, sleep hygiene, exercise encouragement, aromatherapy and/or massage, nutrition consultation, and shared decision-making).
Traditional Chinese Medicine consultation (e.g., acupuncture and/or Chinese herbal medicine) may be provided when clinically indicated.
|
An interdisciplinary integrative care program combining Western supportive care and Traditional Chinese Medicine to manage cancer-related fatigue in hospitalized oncology patients.
Core components include fatigue assessment, patient education and symptom management guidance, sleep hygiene, exercise encouragement, aromatherapy and/or massage, nutrition assessment and counseling, and shared decision-making.
Traditional Chinese Medicine consultation may provide acupuncture and/or Chinese herbal medicine according to patient needs and clinical judgment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cancer-Related Fatigue (CRF) Score (0-10)
Time Frame: From admission (baseline) through discharge (last in-hospital assessment; up to 30 days)
|
CRF is assessed using the Taiwan Society of Cancer Palliative Medicine fatigue scale (0-10) during hospitalization.
Peak CRF score is defined as the maximum recorded CRF score from admission to discharge.
Discharge CRF score is defined as the last in-hospital CRF assessment prior to discharge.
The primary outcome is the within-participant change in CRF score from peak to discharge.
|
From admission (baseline) through discharge (last in-hospital assessment; up to 30 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants With Moderate-to-Profound CRF at Discharge (CRF Score ≥4)
Time Frame: At discharge (last in-hospital assessment; up to 30 days after admission)
|
Percentage of participants whose discharge CRF score is ≥4 (moderate or above) on the Taiwan Society of Cancer Palliative Medicine fatigue scale (0-10).
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At discharge (last in-hospital assessment; up to 30 days after admission)
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Distribution of CRF Severity Categories at Discharge (0, 1-3, 4-6, 7-8, 9-10)
Time Frame: At discharge (last in-hospital assessment; up to 30 days after admission)
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Distribution of discharge CRF scores categorized as 0, 1-3, 4-6, 7-8, and 9-10 on the Taiwan Society of Cancer Palliative Medicine fatigue scale.
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At discharge (last in-hospital assessment; up to 30 days after admission)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2019
Primary Completion (Actual)
April 22, 2020
Study Completion (Actual)
April 22, 2020
Study Registration Dates
First Submitted
February 21, 2026
First Submitted That Met QC Criteria
February 28, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 28, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC110-58
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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