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

NCT ID: NCT04190342

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2021-04-06

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.

Conditions

Breast Neoplasm Female; Symptom Cluster; Tai ji

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

standard care (intervention provided after the completion of the trial)

Group Type: OTHER

control group

Intervention Type: OTHER

A booklet on the self-management of cancer symptoms. After the pilot RCT is completed, if the participants allocated to the control group are interested in practising tai chi, the intervention will be provided

tai chi group

Tai chi intervention + standard care

Group Type: EXPERIMENTAL

tai chi group

Intervention Type: BEHAVIORAL

Around 60 minutes practising easy tai chi movements/postures twice per week

Interventions

control group

A booklet on the self-management of cancer symptoms. After the pilot RCT is completed, if the participants allocated to the control group are interested in practising tai chi, the intervention will be provided

Intervention Type: OTHER

tai chi group

Around 60 minutes practising easy tai chi movements/postures twice per week

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Putian University

OTHER

Sponsor Role: collaborator

Charles Darwin University

OTHER

Sponsor Role: lead

Responsible Party

Jing-Yu Tan, BNSc, MMed, PhD

Professor in Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-Yu (Benjamin) Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

Charles Darwin University

Locations

The Affiliated Hospital of Putian University

Putian, Fujian, China

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34408044 (View on PubMed)

Other Identifiers

H19094

Identifier Type: -

Identifier Source: org_study_id