Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000093987
Ethics application status
Approved
Date submitted
26/01/2011
Date registered
27/01/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial (RCT) of Physical Activity with Breast Cancer Survivors
Scientific title
Breast Cancer Survivor and effect of Physical activity (qigong and aerobic) versus usual care on Quality of Life.
Secondary ID [1] 253489 0
UMMC MEC 805.7
Universal Trial Number (UTN)
Trial acronym
Active Lifestyle
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 258801 0
Condition category
Condition code
Cancer 259173 259173 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved 3 arms where those who met the inclusion criterias and who consented to participate will be exposed to either i) Qigong or ii) Aerobic or iii)Usual care.

The QiGong group session of about 10-15 people will engage in a routine of 'once a week (1x60 minute) class over eight weeks' at the medical centre. It is supervised by trained QiGong Masters. Qi Gong consists of a series of physical exercises which are low-moderate intensity, with lots of breathing exercises. Participants are required to practice (what they learn for that class during the week) for at least two other days in the week at home. A log-book is provided to help them monitor their practices.

The Aerobic group session of about 10-15 people will engage in a routine of 'once a week (1x60 minute) class over eight weeks' at the medical centre. It is supervised by a line-dancing instructor who is also a cancer survivor. The line dance consist of a series of aerobic physical activity which is of low to moderate intensity. Participants are required to practice (what they learn for that class during the week) for at least two other days in the week at home. A log-book is provided to help them monitor their practices.
Intervention code [1] 257733 0
Lifestyle
Intervention code [2] 257734 0
Behaviour
Intervention code [3] 257917 0
Rehabilitation
Comparator / control treatment
Usual care: the participants continues with their hormonal therapy or aromatise inhibitors and attend follow up clinic as instructed by the clinics. All three groups continue with their usual care
Control group
Active

Outcomes
Primary outcome [1] 259808 0
Quality of Life as assessed using the Fact-B
Timepoint [1] 259808 0
Baseline and at Post intervention (8 weeks from baseline)
Secondary outcome [1] 268610 0
Functional Assessment of cancer Therapy-Fatigue (FACT-F)
Timepoint [1] 268610 0
Baseline and at post intervention (8 weeks from baseline)
Secondary outcome [2] 268970 0
Depression Anxiety Stress Scale (DASS)
Timepoint [2] 268970 0
Baseline and at post intervention (8 weeks from baseline)
Secondary outcome [3] 268971 0
Exercise Self-Efficacy Scale (ESS),
Timepoint [3] 268971 0
Baseline and at post intervention (8 weeks from baseline)

Eligibility
Key inclusion criteria
1. Women breast cancer survivors -1 year post diagnosis
2. Had first time diagnosis of stage 1-III (no metastasis)
3. Aged between 18-65 years,
4. Completed primary treatment,
5. Provide consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. BC survivors with metastatic disease
2. Presence of other comorbidities compromising subject’s ability to participate in physical exercise that lasted for 30 minutes per day,
3. Self report physically active (more than 4 hours per week)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
From the list generated from the database, a random allocation software was used to randomise patients to 3 arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 3085 0
Malaysia
State/province [1] 3085 0
Wilayah

Funding & Sponsors
Funding source category [1] 258197 0
University
Name [1] 258197 0
University Malaya Research Grant
Country [1] 258197 0
Malaysia
Primary sponsor type
Individual
Name
Lee Shing Yee
Address
c/o Dr Loh Siew Yim
Department of rehabilitation
Faculty of Medicine
University Malaya
50630, Kuala Lumpur.
Country
Malaysia
Secondary sponsor category [1] 257535 0
Individual
Name [1] 257535 0
Dr Loh Siew Yim
Address [1] 257535 0
Department of rehabilitation
Faculty of Medicine
University Malaya
50630, Kuala Lumpur.
Country [1] 257535 0
Malaysia
Other collaborator category [1] 251728 0
Individual
Name [1] 251728 0
Dr Liam Murray
Address [1] 251728 0
Department of Epidemiology and Public Health,
The Queen's University of Belfast,
Belfast BT9 5E
Country [1] 251728 0
Ireland
Other collaborator category [2] 251730 0
Individual
Name [2] 251730 0
Yip Cheng Har
Address [2] 251730 0
Faculty of Medicine
University Malaya,
50630, Kuala Lumpur
Country [2] 251730 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260183 0
Medical Ethic Committee, University Malaya Medical Centre
Ethics committee address [1] 260183 0
Medical Ethic Committee
University Malaya Medical Centre
50630, Kuala Lumpur
Ethics committee country [1] 260183 0
Malaysia
Date submitted for ethics approval [1] 260183 0
02/07/2010
Approval date [1] 260183 0
02/08/2010
Ethics approval number [1] 260183 0
1/07/0805

Summary
Brief summary
The aim of the trial is to study the effect of physical activity (Qi Gong and aerobic) versus usual care on the Quality of Life (QoL) in breast cancer survivors.
Objectives:
1. To examine whether Qi Gong is a better form of physical activity than the other activity (aerobic /control)).
2. To examine the effect of physical activity on fatigue and distress level of breast cancer survivors.
3. To examine the relationship between self efficacy and QoL.
Null hypothesis:
1. At the end of the 8 week intervention, there is no difference between the physical activity groups (Qi Gong and aerobic ) and control group on the QOL as measured by FACT-G.
2. There will be no difference in QOL between Qi Gong and aerobic group.
3. There will be no relationships of PA on fatigue and distress level of breast cancer survivors.
4. There will be no relationship between self efficacy and QoL
Discussion:
This study will provide evidence on whether participation in physical activity program, especially Qi Gong can enhance the health and QOL of women during their survivorship period. By understanding the outcome, it would help us to help survivors redesign their lifestyle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32006 0
Address 32006 0
Country 32006 0
Phone 32006 0
Fax 32006 0
Email 32006 0
Contact person for public queries
Name 15253 0
Ms LEE SHING YEE
Address 15253 0
c/o Dr Loh Siew Yim
Department of Rehabilitation
Faculty of Medicine
University Malaya
50630, Kuala Lumpur
Country 15253 0
Malaysia
Phone 15253 0
+603 79676612
Fax 15253 0
+603 79674766
Email 15253 0
[email protected]
Contact person for scientific queries
Name 6181 0
Dr LOH SIEW YIM
Address 6181 0
Department of Rehabilitation
Faculty of Medicine
University Malaya
50630, Kuala Lumpur
Country 6181 0
Malaysia
Phone 6181 0
+603 79676612
Fax 6181 0
+603 79674766
Email 6181 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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