NCT06243107

Brief Summary

Cancer patients often experience Cancer-Related Fatigue (CRF) due to surgeries, radiation therapy, and/or chemotherapy. CRF does not improve with sleep or rest and not only affects daily activities but can also significantly reduce quality of life. Therefore, finding ways to alleviate fatigue is crucial for cancer patients. Literature indicates that exercise has demonstrated effectiveness in reducing fatigue. Qigong/Tai Chi, based on movement, is a traditional Chinese mind-body practice falling within the range of low to moderate-intensity aerobic exercise. There is no consistent consensus on the effectiveness and frequency of Qigong/Tai Chi for CRF in different cancer patients. Hence, this study aims to investigate through empirical nursing procedures whether "the practice of Qigong/Tai Chi by cancer patients can improve participants' fatigue. Researchers hope that the results of this study can serve as a reference for future clinical applications in alleviating fatigue among cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started May 2019

Typical duration for not_applicable cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
Last Updated

February 6, 2024

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

December 25, 2023

Last Update Submit

January 28, 2024

Conditions

Cancer

Keywords

cancerFatiguenegative moodquality of lifeSleeping quality

Outcome Measures

Primary Outcomes (1)

  • brief fatigue inventory

    Mendoza et al. developed the Brief Fatigue Inventory (BFI) in 1999 to rapidly assess the level of fatigue in cancer patients. This scale comprises nine questions. The first three questions assess the level of fatigue, including current fatigue, typical fatigue over the past 24 hours, and worst fatigue over the past 24 hours. The remaining six questions assess the impact of fatigue on daily life over the past 24 hours, covering general activities, mood, walking ability, daily work (including work outside the home and household chores), interaction with others, and enjoyment of life. Scores range from 0 to 10, where 0 indicates no fatigue, and 10 represents the worst imaginable level of fatigue. The scores for the nine questions are then summed and averaged, with higher scores indicating higher levels of fatigue and a more significant impact on daily life. Regenerate

    At enrollment, during the first week, second week, fourth week, and eighth week.

Secondary Outcomes (4)

  • Pittsburgh Sleep Quality Index

    t enrollment, during the first week, second week, fourth week, and eighth week

  • Hospital Anxiety and depression Scale

    enrollment, during the first week, second week, fourth week, and eighth week

  • FACIT-G quality of life

    enrollment, during the first week, second week, fourth week, and eighth week

  • Heart rate variability

    enrollment, during the first week, second week, fourth week, and eighth week."

Study Arms (2)

Tai-chi

EXPERIMENTAL

Tai Chi Chuan Intervention: There are 10 styles ,Each movement is performed for 3 minutes, repeated 10 times, totaling 30 minutes per session. participants will engage Tai Chi practice six times a week for eight weeks.

Behavioral: Tai-chi

control

NO INTERVENTION

routine care

Interventions

Tai-chiBEHAVIORAL

Participants will each receive a Tai Chi manual and have access to an instructional audio-visual material via a QR code. The instructional material is tailored specifically for cancer patients. Participants will receive individualized guidance and instructions from the researcher (YH) until they have completed all the executions on the checklist to the required standards.

Tai-chi

Eligibility Criteria

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

You may qualify if:

  • Aged 20 years or older;
  • Diagnosed with tumors and receiving radiation therapy, chemotherapy, or concurrent chemoradiotherapy.
  • Able to communicate and cooperate with the executing team.
  • Willing to participate in this study.

You may not qualify if:

  • Diagnosed with severe internal medical conditions, multiple myeloma, or skeletal metastases.
  • Evidence of medical contraindications for exercise.
  • Regularly practicing health-preserving exercises or other forms of physical activity.
  • Communication barriers, unable to cooperate with the execution of actions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, No.123,Dinghu Rd.,Guishan Dist, 326, Taiwan

Location

Related Publications (4)

  • Wayne PM, Lee MS, Novakowski J, Osypiuk K, Ligibel J, Carlson LE, Song R. Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis. J Cancer Surviv. 2018 Apr;12(2):256-267. doi: 10.1007/s11764-017-0665-5. Epub 2017 Dec 8.

    PMID: 29222705BACKGROUND

  • Zeng Y, Xie X, Cheng ASK. Qigong or Tai Chi in Cancer Care: an Updated Systematic Review and Meta-analysis. Curr Oncol Rep. 2019 Apr 6;21(6):48. doi: 10.1007/s11912-019-0786-2.

    PMID: 30955106RESULT

  • Li W, You F, Wang Q, Shen Y, Wang J, Guo J. Effects of Tai Chi Chuan training on the QoL and psychological well-being in female patients with breast cancer: a systematic review of randomized controlled trials. Front Oncol. 2023 May 1;13:1143674. doi: 10.3389/fonc.2023.1143674. eCollection 2023.

    PMID: 37197428RESULT

  • Song S, Yu J, Ruan Y, Liu X, Xiu L, Yue X. Ameliorative effects of Tai Chi on cancer-related fatigue: a meta-analysis of randomized controlled trials. Support Care Cancer. 2018 Jul;26(7):2091-2102. doi: 10.1007/s00520-018-4136-y. Epub 2018 Mar 21.

    PMID: 29564620RESULT

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Tsang-Tang MD Hsieh, PHD

    Chang Gung Medical Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi-experimental research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

February 6, 2024

Study Start

May 1, 2019

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

February 6, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

This study aims to investigate the effects of Tai Chi intervention on fatigue, sleep quality, levels of anxiety and depression, quality of life, and heart rate variability between the Tai Chi group and the control group. The results of the data can be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
From 2023 to 2025.
Access Criteria
email

Locations

TW(1)