Clinical trial NCT04190342: Effects of a Traditional Chinese Exercise Program on Symptom Cluster in Breast Cancer Patients
Official title: Effects of a Traditional Chinese Exercise Program- Tai Chi on Symptom Cluster of Fatigue-sleep Disturbance-depression in Female Breast Cancer Patients: a Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Symptom Cluster
Tai ji
Keywords: tai chi
breast cancer
symptom cluster
fatigue
sleep disturbance
depression
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
name: The Affiliated Hospital of Putian University
First posted: 2019-12-09
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Medical Research Council Framework for Developing and Evaluating Complex Interventions (MRC Framework) will be utilized to develop and evaluate an evidence-based tai chi intervention for managing the symptom cluster of fatigue-sleep disturbance-depression in breast cancer patients.

Detailed description: The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is regarded as one of the most common symptom clusters among breast cancer (BC) patients. Considering the fact that no specific medications can be recommended to relieve symptom clusters, numerous non-pharmacological interventions have therefore been performed with medication as a combination intervention for the treatment of symptom clusters in cancer patients. Among these interventions, tai chi could be an optimal option for relieving the FSDSC. The overall aims are to develop an evidence-based traditional Chinese exercise (TCE) tai chi protocol, test the feasibility of the protocol, and preliminarily examine the effectiveness of tai chi on the FSDSC and quality of life (QoL) through a pilot randomized controlled trial (RCT). The MRC Framework will be used to develop and evaluate an evidence-based intervention for BC patients. In phase one, an evidence-based TCE tai chi intervention protocol will be developed. An expert panel will then be invited to assess the content validity of the intervention protocol. Testing the feasibility of the tai chi intervention protocol, and preliminarily examining the effects of tai chi on the FSDSC will be conducted in phase two. After completion of the pilot RCT, semi-structured interviews will be conducted to assess the participants' experience of participating in the pilot trial and performing the tai chi exercise. The evidence-based tai chi intervention protocol for managing the FSDSC in breast cancer patients will be developed. The feasibility and effects of utilizing the tai chi intervention for BC patients will be explored. A future multicentre large-scale RCT to further evaluate the effects of tai chi on the FSDSC in the BC population will benefit from the study results of this doctoral research project.

Eligibility criteria: Inclusion Criteria:

1. Female, aged 18 years old or above;
2. a confirmed diagnosis of non-metastatic stage I, II, or IIIa BC;
3. have experienced at least a moderate level of tiredness, sleep disturbance, and depressive mood, with a score of greater than 3 on a 10-point numeric rating scale, from "0 (no symptom)" to "10 (worst symptom)" for each symptom in the previous one month;
4. have recently commenced adjuvant chemotherapy; and
5. able to follow instructions in Mandarin, interested in participating in the study, and willing to sign an informed consent.

Exclusion Criteria:

1. Currently using psychostimulants, antidepressant medications, or hypnotics medications;
2. extremely weak or have mental illness and/or intellectual disability;
3. have been involved in other exercise programs \> 30 minutes, three times weekly, for past 3 months;
4. have practised tai chi for the past six months; and
5. have scheduled elective surgery during the study period.

Primary outcomes:
measure: Time taken to recruit planned sample
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Referral rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Recruitment rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Retention rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Dropout rate
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Reasons for dropping out
timeFrame: From baseline (T1) to the completion of the 8-week intervention (T2)
measure: Feasibility of the questionnaires
timeFrame: Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3)
measure: Adherence rates
timeFrame: Immediately after completion of the 8-week intervention (T2)
measure: Participant feedback
timeFrame: Immediately after completion of the 8-week intervention (T2)
measure: Adverse events associated with the intervention
timeFrame: Immediately after completion of the 8-week intervention (T2)
measure: Number of patients completed the exercise log
timeFrame: Immediately after completion of the 8-week intervention (T2)
Secondary outcomes:
measure: Symptom cluster assessment: fatigue
timeFrame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
measure: Symptom cluster assessment: sleep disturbance
timeFrame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
measure: Symptom cluster assessment: depression
timeFrame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
measure: Quality of life (QoL) assessment
timeFrame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
Other outcomes:
Locations:
city: Putian
country: China
facility: The Affiliated Hospital of Putian University
state: Fujian
city: Luzhou
country: China
facility: The Affiliated Hospital Of Southwest Medical University
state: Sichuan
Study officials:
affiliation: Charles Darwin University
name: Jing-Yu (Benjamin) Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao LQ, Tan JB, Turner C, Wang T. Feasibility and potential effects of tai chi for the fatigue-sleep disturbance-depression symptom cluster in patients with breast cancer: protocol of a preliminary randomised controlled trial. BMJ Open. 2021 Aug 18;11(8):e048115. doi: 10.1136/bmjopen-2020-048115.