Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000975392
Ethics application status
Approved
Date submitted
3/07/2017
Date registered
6/07/2017
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an integrative Tai Chi program affect outcomes for breast cancer patients undergoing cancer therapy?
Scientific title
An integrative Tai Chi program for breast cancer patients undergoing cancer therapy: A randomized controlled feasibility study
Secondary ID [1] 292338 0
Nil known
Universal Trial Number (UTN)
U111111977539
Trial acronym
ANITA (an integrative Tai Chi) Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 303885 0
Condition category
Condition code
Alternative and Complementary Medicine 303247 303247 0 0
Other alternative and complementary medicine
Cancer 303248 303248 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For those participants randomized to the intervention group, they will receive an integrative Tai Chi (ANITA) program that consists of peer support, health education, and Tai Chi Ruler exercise, in addition to breast cancer conventional treatments as described below, This program will run from 4 weeks post-surgery through to participant’s breast cancer treatments.

1) Peer support groups
After group allocation, participants in the intervention group will be invited to join peer support groups hosted by the Otago/Southland Division of the New Zealand Cancer Society. This well-established group is held once per month, being made up of breast cancer patients who have completed cancer therapy and the ones undergoing treatment. The group is formed to be an interactive environment, and provides support and understanding for participants. Furthermore, it serves as a regular social activity and networking opportunity among breast cancer patients.

2) Health education seminars
Seminars will provide participants knowledge for effective self-care and improving quality of life. These seminars will be held every two months at the Otago/Southland Division of the New Zealand Cancer Society, prior to the routine peer support groups. Each seminar will last for 40 minutes, and be delivered by guest speakers with different, relevant expertise such as general practitioner, nutritionist, physiotherapist, and psychotherapist. These sessions will provide participants and their families with knowledge on post-surgery self-care, nutrition, sleep and fatigue, stress management, and social support.

3) Tai Chi Ruler exercise
The 24-weeks exercise program consists of a 12-week instructor-led Tai Chi Ruler class, followed by a 12-week Tai Chi Ruler home-based practice. Tai Chi Ruler is selected as the exercise form as it is easier to learn for beginners than the longer and more complex traditional forms. For the first 12 weeks, participants will be advised to attend a group-based Tai Chi Ruler exercise class at the School of Physiotherapy, twice per week. Class times will be decided at the participants’ convenience to accommodate work and/or treatment schedules, and cohort classes will be provided if necessary. Classes will be instructed by a trained Tai Chi instructor with two years’ experience of leading Tai Chi classes in people with chronic health issues and post-surgery. Exercise protocol for the Tai Chi program will be developed by reviewing previous Tai Chi studies (for breast cancer survivors), and through consultation with an experienced Tai Chi expert at the School of Physiotherapy. Each class will take 60 minutes, consisting of a 15-minute warm-up, 35-minutes of Tai Chi Ruler movements, and a 10-minute cool-down. Participants will be informed that all movements can be performed in a sitting position if necessary; modifications will be made for individuals with range of motion limitations.

On completion of the classes, each participant will receive a CD containing practice music of the Tai Chi Ruler exercise to facilitate their home practice. Participants will be asked to practice Tai Chi Ruler exercise at home (at least) twice per week for 12 weeks; practice will follow the same procedure of the classes. Adherence with the home practice will be captured using a structured activity logbook provided to participants at discharge. Participants are asked to complete the logbooks, and return these logbooks to the blinded research assistant by post on completion of the 12-weeks Tai Chi Ruler home practice. The Tai Chi instructor will follow-up participants by emails or phone calls every two weeks, reinforce the value of exercise adherence, and answer any queries and concerns participants may have.
Intervention code [1] 298516 0
Rehabilitation
Comparator / control treatment
Participants in the control group will be advised to undertake their scheduled breast cancer treatments during the course of the study. This may include any adjuvant cancer therapy (e.g. chemotherapy, radiation therapy, and/or hormonal therapy) at the Dunedin Public Hospital. Data on treatments received by participants throughout the study will be collected through patient medical record review at the end of study.

On completion of the final assessment (24 weeks post randomization) participants will be invited to join the peer support groups hosted by the Otago/Southland Division of the New Zealand Cancer Society (details described in the intervention group). In addition, they will be invited to attend four weekly health education seminars held by the Cancer Society. These seminars will offer participants practical ways of living well during the cancer journey, covering topics such as nutrition, management of emotion and side effects of cancer treatment. Moreover, they will be invited to attend a 2-day workshop on instructor-led Tai Chi Ruler classes at the School of Physiotherapy, consisting of a condensed version of the classes provided to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 302626 0
Feasibility of the recruitment as assessed by recruitment rate and randomization rate
Timepoint [1] 302626 0
Before intervention
Primary outcome [2] 302627 0
Retention rates as assessed by review of research assistant's study follow-up log
Timepoint [2] 302627 0
At 12 weeks post-randomization, and 24 weeks post-randomization
Primary outcome [3] 302628 0
Treatment fidelity as assessed by attendance records for each intervention components (peer support groups, health education seminars, and Tai Chi Ruler exercise) and personal records of the home practice of Tai Chi Ruler exercise kept by each participant.
Timepoint [3] 302628 0
During intervention and at discharge
Secondary outcome [1] 336548 0
Participants’ qualitative outcomes (e.g. acceptability of being involved in the trial, experiences, expectations and satisfaction with the program, and areas for further improvement of the program) as assessed by a focus group discussion with participants randomized into the intervention group
Timepoint [1] 336548 0
On completion of the study
Secondary outcome [2] 336549 0
Participant's fatigue as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4)
Timepoint [2] 336549 0
At baseline, 12 weeks post randomization, and 24 weeks post randomization
Secondary outcome [3] 336552 0
Participant's sleep quality as assessed by the Insomnia Severity Index (ISI)
Timepoint [3] 336552 0
At baseline, 12 weeks post-randomization, and 24 weeks post-randomization
Secondary outcome [4] 336553 0
Participant's anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 336553 0
At baseline, 12 weeks post-randomization, and 24 weeks post-randomization
Secondary outcome [5] 336554 0
Participant's quality of life as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) scale
Timepoint [5] 336554 0
At baseline, 12 weeks post-randomization, and 24 weeks post-randomization
Secondary outcome [6] 336555 0
Safety outcomes (frequency and severity of adverse reactions due to the Tai Chi Ruler exercise) as assessed by the Tai Chi instructor's class logbook and participant's follow-up questionnaires (which were designed specifically for this study)
Timepoint [6] 336555 0
During intervention and at 24 weeks post-randomization

Eligibility
Key inclusion criteria
Participants will be eligible to participate in this trial if they are: (1) patients diagnosed with breast cancer of stage I, II, or III; (2) over 4 weeks since completing surgical treatment; (3) waiting for, or currently undergoing adjunct cancer therapy including chemotherapy, radiation therapy, and/or hormonal therapy; (4) judged as either Grade 0 or 1 of the Eastern Cooperative Oncology Group (ECOG) performance status; (5) willing to be randomized to and to attend the ANITA program at the School of Physiotherapy; (6) able to read and communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from participation in this trial if they have: (1) regular practice of Tai Chi, qigong, or yoga within the past 3 months; (2) a history of health conditions precluding participation in an exercise regime (e.g. severe cardiovascular, liver, or kidney diseases, and severe dementia).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In order to ensure allocation concealment, the trial statistician will place individual randomization numbers into sealed and opaque envelopes. At the first visit to the School of Physiotherapy, participants will choose one of these envelopes, and accordingly be randomly allocated (on a 1:1 basis) to either of two groups: 1) breast cancer conventional therapy alone (n=12); 2) breast cancer conventional therapy plus the ANITA program (n=12).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random allocation sequence will be prepared by the trial statistician prior to participant enrolment based on computer-generated numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a feasibility study, data analysis will be descriptive and provide an estimate of key trial elements to determine whether to proceed a larger definitive RCT.

Demographic data and feasibility outcomes will be classified as continuous or categorical, and appropriate descriptive statistics and percentages will be calculated. Clinical outcomes will be analysed using SPSS (version 22.0) on an intention-to-treat basis. Since this is a feasibility study, tests for significance will not be performed. Data will be represented by point estimates and confidence intervals. Differences from baseline to each interim and the primary endpoint (24 weeks post-randomization) will be calculated, and descriptively compared between groups for the primary endpoint.

Focus group interviews will be analysed using an inductive content analysis. Nvivo (version 9.0) will be used for coding procedures. Two independent coders will read the interview transcripts, and code all data. Inter-rater reliability will be calculated using the kappa statistic; consensus concerning interview content will be reached by discussion between two coders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
24/08/2017
Date of last participant enrolment
Anticipated
31/07/2018
Actual
19/03/2019
Date of last data collection
Anticipated
1/02/2019
Actual
10/09/2019
Sample size
Target
24
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 9036 0
New Zealand
State/province [1] 9036 0
Otago

Funding & Sponsors
Funding source category [1] 296886 0
Charities/Societies/Foundations
Name [1] 296886 0
New Zealand Breast Cancer Foundation
Country [1] 296886 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith St,
North Dunedin,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295893 0
Hospital
Name [1] 295893 0
Dunedin Public Hospital
Address [1] 295893 0
201 Great King Street,
Dunedin 9016
Country [1] 295893 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298106 0
Health & Disability Ethics Committee
Ethics committee address [1] 298106 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298106 0
New Zealand
Date submitted for ethics approval [1] 298106 0
19/06/2017
Approval date [1] 298106 0
27/06/2017
Ethics approval number [1] 298106 0
17/STH/96

Summary
Brief summary
This study will assess the feasibility of a fully-powered randomized controlled trial using an integrative Tai Chi (ANITA) program for breast cancer patients undergoing cancer therapy. We will recruit 24 breast cancer patients from the Breast Cancer Services and the Oncology Department in the Dunedin Hospital. Participants will be recruited over a 12 month window, and subject to informed consent, will be offered the ANITA program in addition to regular cancer treatment. This program will run from 4 weeks post-surgery through to participant’s breast cancer treatments. Analysis will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes (i.e. fatigue, sleep quality, anxiety and depression, and quality of life) will be assessed at baseline, and at 12 weeks and 24 weeks post randomization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76010 0
Dr Lizhou Liu
Address 76010 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 76010 0
New Zealand
Phone 76010 0
+64 3 479 5694
Fax 76010 0
Email 76010 0
[email protected]
Contact person for public queries
Name 76011 0
Dr Lizhou Liu
Address 76011 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 76011 0
New Zealand
Phone 76011 0
+64 3 479 5694
Fax 76011 0
Email 76011 0
[email protected]
Contact person for scientific queries
Name 76012 0
Dr Lizhou Liu
Address 76012 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 76012 0
New Zealand
Phone 76012 0
+64 3 479 5694
Fax 76012 0
Email 76012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn integrative Tai Chi program for patients with breast cancer undergoing cancer therapy: study protocol for a randomized controlled feasibility study.2018https://dx.doi.org/10.1016/j.joim.2017.12.011
N.B. These documents automatically identified may not have been verified by the study sponsor.