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Trial registered on ANZCTR


Registration number
ACTRN12610000712000
Ethics application status
Approved
Date submitted
24/08/2010
Date registered
27/08/2010
Date last updated
26/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The self management of women with breast cancer - Enabling quality of life and participation
Scientific title
Does a 4 week self management program compared to usual care, improve the quality of life of women with breast cancer?
Secondary ID [1] 252567 0
NA
Universal Trial Number (UTN)
Trial acronym
SAMA= "Staying abreast, Moving ahead"
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 258072 0
Mental Health 258073 0
Condition category
Condition code
Cancer 258235 258235 0 0
Breast
Mental Health 258236 258236 0 0
Anxiety
Mental Health 258237 258237 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a 4-week self management program, led by a health care professional with a group of 8-12 patients who meet face-to-face, for 1 1/2 hours a week over 4 weeks. The intervention provides didactic and interactive session using behavioral interventions that focus on managing the medical, emotional and role tasks. It involves training self-management skills -(problem solving, decision making, resource utilization, the formation of a patient-provider partnership, action planning) to enable women to self manage the illness and to improve health behavious. The duration (wash-out period) between experimental and control is 4 weeks.
Intervention code [1] 257083 0
Behaviour
Intervention code [2] 257089 0
Lifestyle
Intervention code [3] 257090 0
Rehabilitation
Intervention code [4] 257103 0
Behaviour
Comparator / control treatment
Usual care is the normal standard of care which may include chemotherapy, radiotherapy and hormonal therapy
Control group
Active

Outcomes
Primary outcome [1] 259073 0
Quality of Life Questionaire - Short Form 36 (SF 36)
Timepoint [1] 259073 0
Baseline, 4 weeks (post-intervention) and 8 weeks (follow-up).
Primary outcome [2] 259074 0
Participation Questionnaire - Inventory of Limitation and Participation (IPA)
Timepoint [2] 259074 0
Baseline, 4 weeks (post-intervention) and 8 weeks (follow-up).
Primary outcome [3] 259075 0
Psychological distress questionaire _ measured with the Depression, Anxiety, Stress Scale (DASS).
Timepoint [3] 259075 0
Baseline, 4 weeks (post-intervention) and 8 weeks (follow-up).
Secondary outcome [1] 265354 0
Self efficacy questionnaire
Timepoint [1] 265354 0
Baseline, 4 weeks (post-intervention) and 8 weeks (follow-up).

Eligibility
Key inclusion criteria
Participants must be newly diagnosed up to one year period, with stage 1-3 Breast cancer and able to give consent.
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 4 Breast cancer
Breast cancer recurrance
Cognitively unable to participate

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects who met inclusion/exclusion criteria and who consented were assigned to the experimental block and then to the control block. (Time series quasi experimental study)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2834 0
Malaysia
State/province [1] 2834 0
Kuala Lumpur
Country [2] 2835 0
Malaysia
State/province [2] 2835 0
Wilayah Persekutuan

Funding & Sponsors
Funding source category [1] 257532 0
University
Name [1] 257532 0
Curtin University of Technology
Address [1] 257532 0
Division of Health Sciences
GPO Box U1987 Perth,
Western Australia 6845.
Country [1] 257532 0
Australia
Funding source category [2] 257540 0
University
Name [2] 257540 0
University Malaya
Address [2] 257540 0
Faculty of Medicine
University Malaya
Jalan University
50630 Kuala Lumpur
Country [2] 257540 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
Health & Translational Fundamental Research
Faculty of Medicine,
University Malaya
50630, Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 256760 0
Charities/Societies/Foundations
Name [1] 256760 0
Malaysian National Cancer Council (MAKNA)
Address [1] 256760 0
National Cancer Council (MAKNA) Malaysia
BG 03A & 05, Ground Floor.
Megan Ambassy,
225 Jalan Ampang,
50450 Kuala Lumpur
Country [1] 256760 0
Malaysia
Other collaborator category [1] 251453 0
University
Name [1] 251453 0
Centre of Research into Disability & Health
Address [1] 251453 0
School of Occupational therapy
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country [1] 251453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259561 0
Medical Research & Ethic Comittee Ministry of Health Malaysia
Ethics committee address [1] 259561 0
Institut for Medical Research,
Jalan Pahang,
50588, Kuala Lumpur
Malaysia
Ethics committee country [1] 259561 0
Malaysia
Date submitted for ethics approval [1] 259561 0
Approval date [1] 259561 0
09/05/2005
Ethics approval number [1] 259561 0
KKM/EPP/02 (160)
Ethics committee name [2] 259562 0
Curtin University of Technology Human Ethics Comittee
Ethics committee address [2] 259562 0
Ethic Comittee
Division of Health Sciences
Curtin University of Technology
GPO Box U1987 Perth
Western Australia 6845
Ethics committee country [2] 259562 0
Australia
Date submitted for ethics approval [2] 259562 0
Approval date [2] 259562 0
09/02/2006
Ethics approval number [2] 259562 0
0T-2005-02
Ethics committee name [3] 259563 0
University Malaya Medical Centre Ethical Comitee
Ethics committee address [3] 259563 0
Ethical comittee
3rd floor UMMC
Lembah Pantai
59100 Kuala Lumpur
Ethics committee country [3] 259563 0
Malaysia
Date submitted for ethics approval [3] 259563 0
Approval date [3] 259563 0
20/04/2005
Ethics approval number [3] 259563 0
435.15

Summary
Brief summary
Clinical Trial on patient self management for women with breast cancer to enable Quality of life (QOL) and Participation. The hypothesis is that the 4 week self management intervention will show statistical differences in the mean-score of the primary outcomes in the experimental groups
Trial website
Trial related presentations / publications
SY Loh (2009). Baseline adjustment for Statistical efficiency on a Clinical Controlled Trial. Journal of University Malaya Medical Centre (JUMMEC) Vol.12, No1 2009 (SCOPUS-Cited Publication
Siew Yim Loh, T.Packer, Cheng-Har Yip, A.Passmore (2009)Targeting Health Disparity in breast cancer: Insights into women's knowledge of their cancer profile with breast cancer. Asian Pacific Journal Cancer Prevention 10, p631-5 (ISI-Cited Publication)
SY Loh, T Packer, WY Low, CH Yip (2007). The Perceived Needs of Malaysian women with Breast Cancer. The Asia Pacific Journal of Public Health 18 (3) p52-7
SY Loh, T Packer, WY Low, CH Yip (2007) Malaysian women with breast cancer: Exploring Needs of Self-management (P2-36) Psycho oncology Journal of the Psychological, social and behavioural dimension of cancer. Vol 16 Number 9 (supplement) September 2007 (ISI-Cited Publication)
Public notes

Contacts
Principal investigator
Name 31567 0
Address 31567 0
Country 31567 0
Phone 31567 0
Fax 31567 0
Email 31567 0
Contact person for public queries
Name 14814 0
Dr Loh Siew Yim
Address 14814 0
University Malaya Medical Centre
Jalan Lembah Pantai
59100 Kuala Lumpur
Country 14814 0
Malaysia
Phone 14814 0
+603 7949 3642
Fax 14814 0
+603 79674766
Email 14814 0
syloh@um.edu.my
Contact person for scientific queries
Name 5742 0
Dr Loh Siew Yim
Address 5742 0
6th Floor, Breast Resource Centre
University Malaya Medical Centre
59100, Jalan Lembah Pantai
Kuala Lumpur
Country 5742 0
Malaysia
Phone 5742 0
+603 79676612
Fax 5742 0
+603 79674766
Email 5742 0
syloh@ummc.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary