Cancer-related FatigueNCT07445243
Integrated Chinese and Western Therapy for Cancer-Related Fatigue
A study testing Integrated Chinese and Western Holistic Care Program in people with Cancer-related Fatigue and Neoplasms (Cancer / Tumors), run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Cancer-related Fatigue, Neoplasms (Cancer / Tumors)
- What is being tested?
- Integrated Chinese and Western Holistic Care Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2019to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refuse to continue participation during the study period, or the family requests discontinuation (withdrawal).
- Psychiatric disorder that makes the participant unable to cooperate.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Integrated Chinese and Western Holistic Care Program
- Keywords
- Holistic care, Integrative medicine, Integrated Chinese and Western medicine, Traditional Chinese Medicine, Chinese herbal medicine, Sleep hygiene, Aromatherapy, Nutrition counseling, Oncology nursing, Cancer-related fatigue
- Medical subject headings
- Neoplasms, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Chinese and Western Holistic Care ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Chinese and Western Holistic Care | Experimental | 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. Receives: Other: Integrated Chinese and Western Holistic Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cancer-Related Fatigue (CRF) Score (0-10)
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.
Measured: From admission (baseline) through discharge (last in-hospital assessment; up to 30 days)
Secondary outcomes (2)
Proportion of Participants With Moderate-to-Profound CRF at Discharge (CRF Score ≥4)
Percentage of participants whose discharge CRF score is ≥4 (moderate or above) on the Taiwan Society of Cancer Palliative Medicine fatigue scale (0-10).
Measured: 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)
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.
Measured: At discharge (last in-hospital assessment; up to 30 days after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start8 Nov 2019
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, nonrandomized, open-label, quasi-experimental evaluation of an interdisciplinary holistic care program for hospitalized adult patients with cancer-related fatigue. The program integrates nursing education, sleep hygiene (optional aromatherapy), exercise promotion, dietician consultation, and Traditional Chinese Medicine modalities.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Ying Chuang, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445243
- Sponsor's protocol ID
- REC110-58
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness Assessment of Integrated Chinese and Western Therapy for Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT07445243
- Acronym / sponsor ID
- REC110-58
- Keywords
- Holistic care, Integrative medicine, Integrated Chinese and Western medicine, Traditional Chinese Medicine, Chinese herbal medicine, Sleep hygiene, Aromatherapy, Nutrition counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 3 Mar 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, nonrandomized, open-label, quasi-experimental evaluation of an interdisciplinary holistic care program for hospitalized adult patients with cancer-related fatigue. The program integrates nursing education, sleep hygiene (optional aromatherapy), exercise promotion, dietician consultation, and Traditional Chinese Medicine modalities.
| Arm | Type | Receives |
|---|---|---|
| Integrated Chinese and Western Holistic Care | Experimental | Other: Integrated Chinese and Western Holistic Care ProgramAll 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. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Refuse to continue participation during the study period, or the family requests discontinuation (withdrawal).
- Psychiatric disorder that makes the participant unable to cooperate.
- -
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 |
|---|---|---|
| Integrated Chinese and Western Holistic Care ProgramAn 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. | Other | Integrated Chinese and Western Holistic Care |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Chinese and Western Holistic Care Program in people with Cancer-related Fatigue and Neoplasms (Cancer / Tumors), run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer-Related Fatigue (CRF) Score (0-10) (time frame: From admission (baseline) through discharge (last in-hospital assessment; up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.