Study design

The study’s design will be a two-parallel-arm, single-blinded (assessor) pilot RCT. The participants will be randomly allocated into two groups: a tai chi intervention group and a control group, with an allocation ratio of 1:1. The study period will be 12 weeks, which will involve an 8-week tai chi intervention and a 4-week follow-up for the intervention group. A Consolidated Standards of Reporting Trials flow chart of the study is presented in figure 1. The schedule of trial enrolment, intervention data collection and assessments are presented in table 1. This protocol was reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials Checklist.

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Figure 1

CONSORT flow chart of the study. BC, breast cancer; CONSORT, Consolidated Standards of Reporting Trials; FSDSC, fatigue-sleep disturbance-depression symptom cluster.

Study setting

This study will be implemented in two tertiary medical centres in Mainland China, including the Affiliated Hospital of Putian University (Fujian) and the Affiliated Hospital of Southwest Medical University (Sichuan).

Sample size calculation

Thirty or more participants per group are usually recommended as sufficient for a pilot study to examine intervention feasibility21 and to estimate a between-group effect for a subsequent power analysis that can be used in the main study’s sample size estimation.22 Given that the primary purpose of this study will be exploring the feasibility and acceptability of the study’s methodological procedures, intervention protocol and questionnaires, 30 participants per group were, therefore, determined to be an appropriate sample size. Taking into account a conservative anticipation of a 20% drop-out rate, the final sample size will therefore be 36 in each group, with a total of 72 participants.23

Inclusion and exclusion criteria

Eligible participants will be recruited using the following inclusion criteria:

1. Adult female patients aged over 18 years.

2. Diagnosed with stage I, II or IIIa BC (non-metastatic BC).

3. Have experienced at least a moderate level of fatigue, sleep disturbance and depression, with a score of greater than 3 (which means a score of ‘4’ and above) on a 10-point scale, from ‘0 (no symptom)’ to ‘10 (worst symptom)’ for each symptom in the past 1 month.

4. Have completed BC surgery for over 1 month.

5. Have recently (within the past 2 months) commenced adjuvant chemotherapy.

6. Able to speak and understand Mandarin Chinese.

7. Willing and able to give written informed consent for study participation.

Potential participants will be excluded using the following exclusion criteria:

1. Presently taking medications for the treatment of fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants or hypnotics.

2. Extremely weak (unable to do physical activities due to advanced stages of chronic illnesses) or have cognitive impairment and/or severe mental illness.

3. Have participated in a tai chi programme during the previous 6 months.

4. Have practised other TCE for over 30 min, three times per week, during the previous 3 months.

5. Have scheduled other elective surgery within the trial period.

Recruitment

A research team will be formed before the commencement of the trial. Three investigators, including the doctoral investigator and two clinical nurses, will be primarily responsible for the subject recruitment and tai chi training. The investigators will receive intensive training from a qualified tai chi instructor to ensure a standardised tai chi practice. Prior to the tai chi intervention, the tai chi instructor will examine the accuracy of the movements among the three researchers, and the accuracy rate should be 100%. Two research assistants will conduct data collection and telephone follow-ups. To ensure the quality of data collection, the two research assistants will be trained on questionnaire data collection skills, including understanding the questionnaire items and standardising their conversations with the participants. The academic supervisors of the doctoral investigator will monitor the entire study procedure on an ongoing basis through regular monthly meetings.

Among the hospitalised patients in the BC unit, potential participants will be recruited directly by the doctoral investigator and the two clinical nurses. Some potential participants who attend a BC clinic for regular follow-ups will be referred by physicians and clinic nurses to the doctoral investigator and the two clinical nurses. A participant information sheet, including the research aim, the procedures and the contact details of the study investigators, will be given to potential participants and will be explained by the doctoral investigator and the two clinical nurses. Potential participants who express interest in participating in the study will be screened for eligibility with reference to the inclusion and exclusion criteria by the doctoral investigator and the two clinical nurses. After their agreement to participate, the participants will be required to provide their written informed consent. The participants will be informed that they can withdraw from the study at any moment without any consequences.

Randomisation and allocation concealment

The pilot trial will be randomised and controlled in a 1:1 allocation ratio. One set of randomisation sequences will be generated via an online randomiser (https://www.randomizer.org/) based on the estimated sample size. To ensure allocation concealment, the randomisation sequences will be generated by a statistician who will not be involved in any other parts of this study. Specifically, the statistician will use the online randomiser to generate the randomisation sequences, which will include 36 even and 36 odd numbers. The randomisation sequences will be accessed by the statistician only. Once an eligible participant consents to participate in the study and completes the baseline assessment, the two clinical nurses will telephone the statistician to determine which group the patient should be assigned to according to the predefined random numbers. The participants will be randomly assigned to either the tai chi intervention group or the control group.

Blinding

Due to the visible nature of the tai chi intervention, blinding of the study investigators and the participants will be impossible. Thus, blinding will only be applied to the outcome assessors (ie, the two research assistants) in this pilot RCT to avoid potential detection bias during data collection. The two research assistants will be responsible for data collection and telephone follow-ups, and they will not be involved in the subject recruitment process.

Tai chi intervention group

In addition to the standard care provided to both the intervention group and the control group, the participants in the intervention group will additionally receive instruction on easy eight form tai chi movements. The development and validation of the evidence-based tai chi protocol are detailed in a methodological paper.24 The intervention regimen will last 60 min per session, two sessions per week, for 8 weeks, which is based on current research evidence, practice standards/guidelines, theories and experts’ consensus.24 To ensure that the participants have fully mastered the tai chi skills, before the commencement of the intervention, they will receive at least three 60 min training sessions until they can perform the movements correctly and smoothly, along with a home learning package in an audiovisual format (ie, a recorded video). The training will be conducted and led by either the doctoral investigator or the two clinical nurses, and attendance will be recorded. All the participants will be asked to perform the tai chi movements in front of the trainers (ie, return demonstration) to make sure that they are correctly performing each movement of the tai chi exercise. In addition, the participants will be tested by the trainers during the last training session to ensure that they have correctly performed the tai chi movements (via return demonstration).

Each tai chi session will be 60 min and will be comprised of the following components: a 10 min warm-up, 25–30 min of easy 8 form tai chi practising, and a 10 min cool-down. During each session, the participants will also have a 10 min break to rest. The tai chi intervention protocol was adapted in clinical practice to develop a personalised intervention that will be tailored to the participants’ convenience and preference regarding the time and venue of the intervention. Details of the tai chi protocol are presented in a methodological paper.24 A specially designed exercise log will be provided to the participants to record information related to their tai chi practice immediately after tai chi practising each time, such as duration and frequency of practising tai chi, as well as any potential adverse reactions related to tai chi, such as dizziness, knee pain, musculoskeletal aches and pains, etc. The exercise logs will be returned to the research assistants on the date of the participants’ treatment or follow-up appointment at the hospital. To enhance the participants’ adherence to the tai chi intervention, the research assistants will conduct telephone follow-ups every week to remind them to practise their tai chi and to collect information on any potential adverse reactions related to the tai chi intervention.

Control group

The participants allocated to the control group will receive a standard care package, which will be a booklet on the self-management of cancer symptoms. This booklet will offer basic knowledge and management strategies regarding FSDSC management in patients with BC during or after chemotherapy treatment. All the information listed in this booklet will be comprehensively adapted from relevant national guidelines developed by professional associations in cancer care and government health department websites, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (the NCCN Guidelines)25 and the Department of Health-Government of Western Australia.26 Research evidence in published peer-reviewed articles will also be cited as supporting information for the booklet’s development.2 27–29 Additionally, the participants will be asked to refrain from practising any exercises related to TCE during the study, with reminders at all assessment time points. On completion of the pilot RCT, the participants in the control group will have an opportunity to receive the tai chi training from the study team.

Outcome measurements and follow-up

The outcome measurements for this pilot RCT will include three categories, namely, baseline assessments, feasibility and acceptability outcomes, and clinical outcomes. The feasibility and acceptability outcomes will be the primary outcomes, while the clinical outcomes will be the secondary outcomes. All the outcomes and follow-ups will be conducted by the two research assistants.

Demographic and clinical characteristics of the participants

A self-designed demographic and clinical data form will be employed to collect the participants’ sociodemographic data (eg, age, education background, employment status, marital status and household income) and medical history (eg, date of diagnosis, the current stage of BC and date and type of treatment) at baseline (T1).

Primary outcomes: feasibility and acceptability

1. The feasibility assessment of subject recruitment and the follow-up process will include: (1) the time that was taken to recruit the planned sample size of participants; (2) referral rate—the number of referrals made by clinicians in different departments and hospitals divided by all referrals; (3) recruitment rate—the number of subjects who enrolled in the study divided by all subjects eligible for enrolment; (4) retention rate—the number of subjects who completed the study divided by all subjects who enrolled in the study; (5) drop-out rate—the number of subjects who dropped out after randomisation divided by all subjects who enrolled in the study and (6) feedback from the drop-out subjects to identify their reasons for dropping out. The feasibility of recruitment and follow-up process outcomes will be collected from baseline (T1) to the completion of the intervention (T2).

2. The feasibility assessment of the outcome measures will include the percentage of missing values for each item of the scales used—the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS) and the Functional Assessment of Cancer Therapy-Breast (FACT-B)—at baseline (T1), immediately after the intervention (T2) and 4 weeks after completion of the intervention (T3).

3. The feasibility and acceptability of the intervention will include: (1) adherence rates—the number of tai chi sessions practised divided by the total number of sessions required; (2) the participants’ feedback on and satisfaction with the intervention using a self-designed feedback form; (3) records of adverse events associated with tai chi, which will be obtained from the exercise logs and (4) the number of participants who completed the exercise log. The feasibility and acceptability of the intervention will be assessed immediately after the intervention (T2).

Secondary outcomes: fatigue, sleep disturbance, depression and QOL

The fatigue, sleep disturbance, depression and QoL of the patients with BC as the secondary outcomes will be measured at T1, T2 and T3 using the BFI, the PSQI, the HADS and the FACT-B.

1. Fatigue: The participants’ severity of fatigue and cancer-related fatigue in daily functioning will be measured using the BFI. The BFI has nine items, with higher scores corresponding to more severe fatigue.30 31 The Chinese version of the BFI has excellent internal consistency reliability (Cronbach’s alpha from 0.90 to 0.92), as well as construct validity and convergent validity.32

2. Sleep disturbance: The participants’ sleep quality and disturbance will be assessed using the PSQI. This questionnaire has seven domains: sleep latency, habitual sleep efficiency, subjective sleep quality, sleep duration, use of sleeping medication, sleep disturbance and daytime dysfunction.33 A total score will be calculated from the sum of the seven domains’ scores. A higher total score indicates poorer sleep quality. The Chinese version of the PSQI has been demonstrated to be a reliable and valid scale, and it has been widely used among patients with cancer.34

3. Depression: The HADS will be used to assess the participants’ depression. The cut-off scores have been classified and labelled as 0–7 for ‘normal’, 8–10 for ‘mild’, 11–15 for ‘moderate’ and ≥16 for ‘severe’.35 As a reliable and valid tool for measuring depression, the HADS has been widely used among Chinese patients with cancer, with well-documented psychometric properties.36

4. QoL: The FACT-B will be adopted to assess the participants’ QoL. A higher score demonstrates better QoL. The FACT-B is available in a simplified Chinese version, with adequate psychometric properties reported among patients with BC.37

Data management

The doctoral investigator and one of the research assistants will enter all the collected data into a computer with a double data entry approach. To ensure that there are no discrepancies or coding errors after running descriptive and inferential statistics, data cleaning will be conducted before data analysis.38 First, the datasets will be checked against the paper recordings of raw data to ensure that the data coding is correct. Then, double-checking will be undertaken by the other research assistant to ensure accuracy. All electronic data will be retained in a compressed folder using password-protected access systems, and all hard copies of the materials will be retained in a cabinet at the study sites. Storage and disposal of research data hard copies will strictly follow the regulations and policies of the lead investigator’s institution and the study sites, including the Charles Darwin University Research Data Management Guide.

Data analysis

Statistical analyses will be conducted using IBM SPSS Statistics for Windows, V.24.0 (IBM). The intention-to-treat principle will be used for the management of missing data. Effect sizes of between-group comparisons will be estimated using Cohen’s d.39 The χ² test or Fisher’s exact test will be used to examine the comparisons between the control and intervention groups for categorical variables (eg, education background, referral rate, retention rate, etc). An independent t-test or the Mann-Whitney U test will be used for the continuous variables (eg, age). The generalised estimating equation model will be performed for repeated multivariate analysis between the two study groups for the total scores and domain scores of the BFI, the PSQI, the HADS and the FACT-B. The significance level to identify statistical differences will be p<0.05.

Patient and public involvement

No patient was involved in the study design or any other part of this protocol.

Ethics and dissemination

The study has been approved by the Human Research Ethics Committee at Charles Darwin University (H19094), the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2019133) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Putian University (201932). The abstract of this study has been submitted to Sigma’s 32nd International Nursing Research Congress for presentation in 2021. The results of the trial will be published in peer-reviewed scientific journals.