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

March 11, 2022 updated by: Jing-Yu Tan, BNSc, MMed, PhD, Charles Darwin University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Putian, Fujian, China, 350011
        • The Affiliated Hospital of Putian University
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Southwest Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: control group
standard care (intervention provided after the completion of the trial)
Other: 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
Experimental: tai chi group
Tai chi intervention + standard care
Behavioral: tai chi group
Around 60 minutes practising easy tai chi movements/postures twice per week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time taken to recruit planned sample
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: From baseline (T1) to the completion of the 8-week intervention (T2)
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
Time Frame: Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3)
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
Time Frame: Immediately after completion of the 8-week intervention (T2)
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
Time Frame: Immediately after completion of the 8-week intervention (T2)
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
Time Frame: Immediately after completion of the 8-week intervention (T2)
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
Time Frame: Immediately after completion of the 8-week intervention (T2)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom cluster assessment: fatigue
Time Frame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
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)
Symptom cluster assessment: sleep disturbance
Time Frame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
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)
Symptom cluster assessment: depression
Time Frame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
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)
Quality of life (QoL) assessment
Time Frame: Baseline Assessments (T1); Immediately after completion of the 8-week intervention (T2); 4-week Follow-up (T3)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles Darwin University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital Of Southwest Medical University
The Affiliated Hospital of Putian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing-Yu (Benjamin) Tan, PhD, Charles Darwin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H19094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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