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

NCT04190342 | Completed DMC

• 1 other identifier: H19094
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasm Female; Symptom Cluster; Tai ji

Keywords

tai chi; breast cancer; symptom cluster; fatigue; sleep disturbance; depression

Outcome Measures

Primary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Symptom cluster assessment: fatigue

  Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)

• Symptom cluster assessment: sleep disturbance

  Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)

• Symptom cluster assessment: depression

  Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)

• Quality of life (QoL) assessment

  Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)

Study Arms (2)

control group

OTHER

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

Other: control group

tai chi group

EXPERIMENTAL

Tai chi intervention + standard care

Behavioral: tai chi group

Interventions

control group 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

control group

tai chi group BEHAVIORAL

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

tai chi group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Darwin University: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator
• The Affiliated Hospital of Putian University: collaborator

Study Sites (2)

The Affiliated Hospital of Putian University

Putian, Fujian, 350011, China

Location

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (1)

• 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.

  PMID: 34408044 DERIVED

MeSH Terms

Conditions

Syndrome; Breast Neoplasms; Fatigue; Parasomnias; Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jing-Yu (Benjamin) Tan, PhD

  Charles Darwin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Nursing

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: May 4, 2020
• Primary Completion: February 22, 2021
• Study Completion: April 6, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

CN (2)