Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Time taken to recruit planned sample |
the time that was taken to recruit the planned sample size of participants |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Referral rate |
The number of referrals made by clinicians in different departments and hospitals divided by all referrals |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Recruitment rate |
The number of subjects who enrolled in the study divided by all subjects eligible for enrolment |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Retention rate |
The number of subjects who completed the study divided by all subjects who enrolled in the study |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Dropout rate |
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Reasons for dropping out |
Feedback from the dropout subjects to identify their reasons for dropping out |
From baseline (T1) to the completion of the 8-week intervention (T2) |
|
| Primary |
Feasibility of the questionnaires |
The percentage of missing values for each item of the scales used, including 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) |
Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3) |
|
| Primary |
Adherence rates |
The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions |
Immediately after completion of the 8-week intervention (T2) |
|
| Primary |
Participant feedback |
Participants' feedback on and satisfaction with the intervention using a self-designed feedback form |
Immediately after completion of the 8-week intervention (T2) |
|
| Primary |
Adverse events associated with the intervention |
In each tai chi session, the subjects in the intervention group will record whether they had any uncomfortable feelings |
Immediately after completion of the 8-week intervention (T2) |
|
| Primary |
Number of patients completed the exercise log |
The participants in the tai chi group will be required to keep a diary to monitor their tai chi exercise after each tai chi session |
Immediately after completion of the 8-week intervention (T2) |
|
| Secondary |
Symptom cluster assessment: fatigue |
Fatigue will be measured by the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory includes nine items using a 0- to 10-point Likert scale, where 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine" . The global BFI score, with a range between 0 and 90, is calculated as the mean of the nine items, and higher scores correspond to more severe fatigue |
Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3) |
|
| Secondary |
Symptom cluster assessment: sleep disturbance |
Sleep disturbance will be measured by the Pittsburgh Sleep Quality Index (PSQI). This 19-item questionnaire consists of seven components: subjective sleep quality (one item), sleep latency (two items), sleep duration (one item), habitual sleep efficiency (three items), sleep disturbance (nine items), use of sleeping medications (one item), and daytime dysfunction (two items). Each of the seven component scores are identified based on scoring algorithms, with each item using a 4-point Likert response scale, ranging from 0 to 3. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher score on the global (total) score indicates poorer sleep quality. |
Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3) |
|
| Secondary |
Symptom cluster assessment: depression |
depression will be measured by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, self-report scale that includes two subscales, namely, the Anxiety subscale (HADS-A) and the depression subscale (HADS-D), which has seven items per subscale. The scale uses a 4-point Likert scale, ranging from 0 to 3. The sum of the ratings of 14 items yields a total score; the sum of the ratings of seven items in each subscale yields separate scores for anxiety and depression. The score ranges between 0 and 42 for the total score and between 0 and 21 for each subscale. Higher scores indicate greater severity of anxiety and depression. |
Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3) |
|
| Secondary |
Quality of life (QoL) assessment |
Quality of life assessment will be measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B). The FACT-B is subdivided into four primary QoL domains, namely, Physical Well-Being (seven items), Social Well-Being (seven items), Emotional Well-Being (six items), and Functional Well-Being (seven items), and contains additional concerns for Beast Cancer (10 items) . The FACT-B has a 5-point Likert-type response scale, ranging from 0 to 4, where 0 = "not at all" and 4 = "very much". A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. Moreover, a higher FACT-B score indicates a better QoL status. |
Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3) |
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