NCT07445243

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 21, 2026

Last Update Submit

February 28, 2026

Conditions

Keywords

Holistic careIntegrative medicineIntegrated Chinese and Western medicineTraditional Chinese MedicineChinese herbal medicineSleep hygieneAromatherapyNutrition counselingOncology nursingCancer-related fatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    At discharge (last in-hospital assessment; up to 30 days after admission)

Study Arms (1)

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.

Other: Integrated Chinese and Western Holistic Care Program

Interventions

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.

Integrated Chinese and Western Holistic Care

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Refuse to continue participation during the study period, or the family requests discontinuation (withdrawal).
  • Psychiatric disorder that makes the participant unable to cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, 42743, Taiwan

Location

MeSH Terms

Conditions

NeoplasmsSleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 21, 2026

First Posted

March 3, 2026

Study Start

November 8, 2019

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations