Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000402640
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
14/09/2005
Date last updated
8/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Fertility-Related Decision Aid for Young Women with Early Breast Cancer.
Scientific title
The Impact of a Fertility-Related Decision Aid for Young Women with Early Breast Cancer on Psychological and Decision Related Outcomes.
Universal Trial Number (UTN)
Trial acronym
Fertility-DA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 508 0
Condition category
Condition code
Cancer 586 586 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will be recruited prospectively prior to the commencement of any adjuvant therapy through 22 oncology clinics nation-wide. During the first year of recruitment, women will be given an information booklet developed by the National Breast Cancer Centre for consumers (control). In the second year of recruitment women will be given the decision aid (an information tool desigened to assist with decision making).
Intervention code [1] 3569 0
Other interventions
Comparator / control treatment
'During the first year of recruitment, women will be given an information booklet developed by the National Breast Cancer Centre for consumers (control) that describes early breast cancer, treatment, pathology, symptoms, side effects etc.
Control group
Placebo

Outcomes
Primary outcome [1] 680 0
Informed choice about fertility-related decisions measured by the Multidimensional Measure of Informed Choice
Timepoint [1] 680 0
At baseline and 1 month
Secondary outcome [1] 1392 0
Knowledge of the impact of different therapy regimens on fertility.
Timepoint [1] 1392 0
At baseline, 1 month and 12 months.
Secondary outcome [2] 1393 0
Available ARTs and the impact of pregnancy after breast cancer on prognosis and survival over three time-points.
Timepoint [2] 1393 0
Baseline, 1 month and 12 months
Secondary outcome [3] 1394 0
Anxiety and depression measured by the Hospital Anxiety and Depression Scale.
Timepoint [3] 1394 0
At baseline, 1 month and 12 months.

Eligibility
Key inclusion criteria
Women at time of diagnosis of a histologically confirmed early-stage breast cancer; pre-menopausal at time of diagnosis and not having completed their families; no history of metastatic disease; able to read English proficiently and to give informed written consent; recently diagnosed and not yet commenced adjuvant therapy.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Block design
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 640 0
Charities/Societies/Foundations
Name [1] 640 0
Cancer Council of NSW
Country [1] 640 0
Australia
Primary sponsor type
Individual
Name
Bettina Meiser
Address
Psychosocial Research Group, Department of Medical Oncology,
Level 3, Dickinson Bld,
Prince of Wales Hospital,
Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 532 0
Individual
Name [1] 532 0
Michelle Peate
Address [1] 532 0
PRG, Dept of Med Onc,
Level 3, Dickinson Bld,
Prince of Wales Hospital,
Randwick, NSW 2031
Country [1] 532 0
Australia
Secondary sponsor category [2] 533 0
Individual
Name [2] 533 0
Michael Friedlander
Address [2] 533 0
Dept of Med Onc,
Prince of Wales Hospital,
Randwick, NSW 2031
Country [2] 533 0
Australia
Secondary sponsor category [3] 534 0
Individual
Name [3] 534 0
Martha Hickey
Address [3] 534 0
School of Women?s and Infants? Health, University of Western Australia, King Edward Memorial Hospital,
374 Bagot Road,
Subiaco, WA 6008
Country [3] 534 0
Australia
Secondary sponsor category [4] 535 0
Individual
Name [4] 535 0
Belinda Thewes
Address [4] 535 0
Centre for Medical Psychology & Evidence-based Decision-making
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country [4] 535 0
Australia
Secondary sponsor category [5] 536 0
Individual
Name [5] 536 0
Christobel Saunders
Address [5] 536 0
School of Surgery,
University of Western Australia
Crawley, 6009
Country [5] 536 0
Australia
Secondary sponsor category [6] 537 0
Individual
Name [6] 537 0
Helen Zorbas
Address [6] 537 0
Level 1, Suite 103,
355 Crown Street,
Surry Hills, NSW 2010
Country [6] 537 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Each year approximately 10,000 women are diagnosed with breast cancer in Australia, making this the most frequently diagnosed cancer in reproductive age women. Approximately 6-7% of these women are under 40 years at the time of their diagnosis. All patients faced with decisions about treatment for cancer need to weigh up the benefits and side-effects of treatment. This issue is particularly relevant in considering the effects of treatment on future fertility. The prognosis in terms of survival for young women is often excellent, but permanent ovarian failure and hence infertility as a result of adjuvant chemotherapy is a common consequence. For many young women, this is of enormous importance. Yet, many are not fully informed of the potential adverse reproductive effects of chemotherapy or fail to take in the possible consequences of treatment while making treatment decisions shortly after the diagnosis of breast cancer. Our objective is to conduct a comprehensive nation-wide prospective study to compare the efficacy of a fertility-related decision aid (an information tool specifically designed to assist with decision-making) to usual care amongst young women with early breast cancer. The decision aid will present information on choice of chemotherapeutic agents, Assisted Reproductive Technology (ART) options and the impact of pregnancy following diagnosis on prognosis. Following pilot-testing, the decision aid will be tested in a prospective nationwide study involving 17 oncology clinics, and young women with early breast cancer will be recruited prior to commencement of any adjuvant therapy. Data will be collected prior to commencement of adjuvant therapy, and 1 and 12 months following this, using self-administered questionaries assessing a range of variables, using validated measures of psychological and decision-related outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35208 0
Address 35208 0
Country 35208 0
Phone 35208 0
Fax 35208 0
Email 35208 0
Contact person for public queries
Name 9576 0
Ms Michelle Peate
Address 9576 0
Psychosocial Research Group
Department of Medical Oncology
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 9576 0
Australia
Phone 9576 0
+61 2 93824229
Fax 9576 0
+61 2 93823372
Email 9576 0
[email protected]
Contact person for scientific queries
Name 504 0
Ms Michelle Peate
Address 504 0
Psychosocial Research Group
Department of Medical Oncology
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 504 0
Australia
Phone 504 0
+61 2 93824229
Fax 504 0
+61 2 93823372
Email 504 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.