Effects of a Traditional Chinese Exercise Program on Symptom Cluster in Breast Cancer Patients

Charles Darwin University

Status

Completed

Conditions

Symptom Cluster

Tai ji

Breast Neoplasm Female

Treatments

Behavioral: tai chi group

Other: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT04190342

H19094

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female, aged 18 years old or above;
a confirmed diagnosis of non-metastatic stage I, II, or IIIa BC;
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;
have recently commenced adjuvant chemotherapy; and
able to follow instructions in Mandarin, interested in participating in the study, and willing to sign an informed consent.

Exclusion criteria

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