ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12626000050358

Ethics application status

Approved

Date submitted

9/12/2025

Date registered

13/01/2026

Date last updated

13/01/2026

Date data sharing statement initially provided

13/01/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility study of a co-designed Tai-Chi intervention for managing the fatigue, sleep-disturbance and depression symptom cluster for breast cancer survivors in regional Australia.

Scientific title

Feasibility study of a co-designed Tai-Chi intervention for managing the fatigue, sleep-disturbance and depression symptom cluster for breast cancer survivors in regional Australia.

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Fatigue

Sleep-disturbance

Depression

Breast cancer

Condition category

Condition code

Mental Health

Depression

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is a Tai Chi (TC) form called Easy 8 Form Yang Style Tai Chi, based on a previous small, randomised control trial (RCT) in China with breast cancer (BC) patients experiencing the fatigue, sleep-disturbance and depression symptom cluster (FSDSC) (Yao et al., 2022). The low-intensity TC protocol will be delivered by a trained Tai Chi instructor with a member of the research team supervising sessions, to a group of BC survivors with FSDSC in the form of an 8-week course of weekly group classes, each lasting one hour. A member of the research team will record and document participant attendance at each session to help calculate the proportion of participants who complete a minimum of 80% of the TC course and the retention rate.

Reference
Yao, L.Q., et al., The effect of an evidence-based Tai chi intervention on the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients: A preliminary randomised controlled trial. European Journal of Oncology Nursing, 2022. 61

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Description of the comparator or control

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Retention rate

Timepoint [1]

Immediately post-intervention (8 weeks)

Primary outcome [2]

Outcome assessment completion rate.

Timepoint [2]

Baseline (0 weeks), immediately post-intervention (8 weeks) and 4 weeks post-intervention

Primary outcome [3]

Acceptability

Timepoint [3]

Immediately post-intervention (8 weeks).

Secondary outcome [1]

Experiences of participating in the TC protocol study

Timepoint [1]

Immediately post-intervention (8 weeks).

Secondary outcome [2]

Fatigue symptoms

Timepoint [2]

Baseline (0 weeks), immediately post-intervention (8 weeks) and 4 weeks post-intervention.

Secondary outcome [3]

Depression symptoms

Timepoint [3]

Baseline (0 weeks), immediately post-intervention (8 weeks) and 4 weeks post-intervention.

Secondary outcome [4]

Sleep quality

Timepoint [4]

Baseline (0 weeks), immediately post-intervention (8 weeks) and 4 weeks post-intervention.

Secondary outcome [5]

Quality of Life

Timepoint [5]

Baseline (0 weeks), immediately post-intervention (8 weeks) and 4 weeks post-intervention.

Eligibility

Key inclusion criteria

Breast cancer survivors will be eligible to participate if they:
1. Have been diagnosed with Stage 1, 2 or 3 breast cancer
2. Have completed adjuvant chemotherapy for breast cancer for at least a month and up to 3 years
3. Have experienced at lease a moderate level (at least 3/10) of tiredness, sleep disturbance, and depressive mood in the previous month.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Breast cancer survivors will be excluded from participating if they:
1. are currently using psychostimulant or hypnotic medications,
2. have elective surgery scheduled during the study period.
3. have stage 4 breast cancer
4. are unable to stand safely for 10 minutes
5. have unstable medical conditions
6. have a cognitive impairment preventing informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The clinical outcome data will be statistically analysed using SPSS 24.0 software package. The total and sub-scale scores of the BFI, PSQI, HADS, and FACT-B will be summarised for each time point by calculating the mean, the range, and the standard deviation. Repeated measures ANOVA will provide estimates of the significance of any difference between the mean outcome scores of the group between T1 and T2, T1 and T3, and T2 and T3, with p<.05 significance level.

Each participant’s scores on the outcome measures will be graphically represented to show any changes between the time points. These will be compared to the participant’s interview responses for correlations. Any contrasts may be investigated further with the participant for a deeper understanding of their experience

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/01/2026

Actual

Date of last participant enrolment

Anticipated

30/09/2026

Actual

Date of last data collection

Anticipated

26/02/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Research Training Program Scholarship, DOI.org/10.82133/C42F-K220

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Charles Darwin University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Charles Darwin University Human Research Ethics Committee

Ethics committee address [1]

https://www.cdu.edu.au/research-and-innovation/research-ethics-and-integrity/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/09/2025

Approval date [1]

11/11/2025

Ethics approval number [1]

H25108

Summary

Brief summary

This study aims to adapt a specific Tai Chi program for a regional Australian community to determine if it is a feasible and helpful way to manage symptoms of fatigue, sleep disturbance, and depression in breast cancer survivors.

Who is it for?
You may be eligible for this study if you are a female aged 18 or older, completed chemotherapy for Stage 1, 2, or 3 breast cancer within the last three years and are currently experiencing moderate levels of tiredness, sleep problems, and low mood.

Study details:
Participants will attend a weekly, one-hour Tai Chi class (the "Easy 8 Form Yang Style") for a total of 8 weeks. All participants in this study will receive the Tai Chi training. Participants will complete assessments to monitor their symptoms at the start of the study, at the end of the 8-week program, and again four weeks later.

It is hoped this research will determine if this Tai Chi program is an acceptable and effective therapy to help improve the well-being and symptom recovery of Australian breast cancer survivors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Brona Nic Giolla Easpaig

Address

Charles Darwin University, 815 George St, Haymarket NSW 2000

Country

Australia

Phone

+61 02 8047 4100

Fax

[email protected]

Contact person for public queries

Name

Brona Nic Giolla Easpaig

Address

Charles Darwin University, 815 George St, Haymarket NSW 2000

Country

Australia

Phone

+61 02 8047 4100

Fax

[email protected]

Contact person for scientific queries

Name

Brona Nic Giolla Easpaig

Address

Charles Darwin University, 815 George St, Haymarket NSW 2000

Country

Australia

Phone

+61 02 8047 4100

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: This would not be appropriate for the study owing to privacy and confidentiality concerns. In addition shared IPD would not be consented to as part of the informed consent process.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically