AzTrials
AzTrials

Breast Neoplasm FemaleNCT04190342

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

A study testing tai chi group in people with Breast Neoplasm Female and Symptom Cluster, run by Charles Darwin University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasm Female, Symptom Cluster, Tai ji
What is being tested?
tai chi group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesChina
Study dates
4 May 2020to 6 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The Affiliated Hospital Of Southwest Medical University

    Luzhou, Sichuan, 646000

  • The Affiliated Hospital of Putian University

    Putian, Fujian, 350011

Other trials in China

About this study

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

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.

Read the 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.

Being tested
control group, tai chi group
Keywords
tai chi, breast cancer, symptom cluster, fatigue, sleep disturbance, depression
Medical subject headings
Syndrome, Breast Neoplasms, Fatigue, Parasomnias, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • control groupOther

    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 groupBehavioural

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

Study groups in NCT04190342
Study groupRoleWhat they receive
control groupOtherstandard care (intervention provided after the completion of the trial)
Receives: Other: control group
tai chi groupExperimentalTai chi intervention + standard care
Receives: Behavioral: tai chi group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken to recruit planned sample

    the time that was taken to recruit the planned sample size of participants

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  2. Referral rate

    The number of referrals made by clinicians in different departments and hospitals divided by all referrals

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  3. Recruitment rate

    The number of subjects who enrolled in the study divided by all subjects eligible for enrolment

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  4. Retention rate

    The number of subjects who completed the study divided by all subjects who enrolled in the study

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  5. Dropout rate

    The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  6. Reasons for dropping out

    Feedback from the dropout subjects to identify their reasons for dropping out

    Measured: From baseline (T1) to the completion of the 8-week intervention (T2)

  7. 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)

    Measured: Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3)

  8. Adherence rates

    The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions

    Measured: Immediately after completion of the 8-week intervention (T2)

  9. Participant feedback

    Participants' feedback on and satisfaction with the intervention using a self-designed feedback form

    Measured: Immediately after completion of the 8-week intervention (T2)

  10. 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

    Measured: Immediately after completion of the 8-week intervention (T2)

  11. 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

    Measured: Immediately after completion of the 8-week intervention (T2)

Secondary outcomes (4)

  1. Symptom cluster assessment: fatigue

    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

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

  2. Symptom cluster assessment: sleep disturbance

    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.

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

  3. Symptom cluster assessment: depression

    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.

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

  4. Quality of life (QoL) assessment

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start4 May 2020
  3. Primary completion22 Feb 2021
  4. Study completion6 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190342
Sponsor's protocol ID
H19094
Status last verified
Mar 2022
First submitted
3 Dec 2019
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34408044

Questions about this trial

What is this clinical trial studying?

A study testing tai chi group in people with Breast Neoplasm Female and Symptom Cluster, run by Charles Darwin University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken to recruit planned sample (time frame: From baseline (T1) to the completion of the 8-week intervention (T2)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in