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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • Taichung, Taiwan, 42743
        • Taichung Tzu Chi Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Integrated Chinese and Western Holistic Care Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
At discharge (last in-hospital assessment; up to 30 days after admission)
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)
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Tzu Chi Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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