Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001364561
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
16/12/2015
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a fertility decision aid utilising health literacy principles for younger women with breast cancer.
Scientific title
Evaluating the impact of a fertility decision aid developed using health literacy principles, compared to standard care, on decision-related outcomes in younger women with breast cancer.
Secondary ID [1] 286692 0
Nil
Universal Trial Number (UTN)
U1111-1170-1252
Trial acronym
aLLIAnCE (Low Literacy Decision Aid about Reproductive Choices for Younger Women with Breast Cancer) study

Fertility Choices Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 295038 0
Low Health Literacy 295039 0
Decision-making 295040 0
Fertility preservation 295043 0
Condition category
Condition code
Cancer 295296 295296 0 0
Breast
Reproductive Health and Childbirth 295297 295297 0 0
Fertility including in vitro fertilisation
Mental Health 295299 295299 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a low-literacy decision aid (DA) designed to assist patients to reach an informed decision about fertility preservation. The DA has been developed in accordance with the latest International Patient Decision Aid Standards (IPDAS) established by a group of experts. The content will be based on a literature review and consultation with experts, including health literacy experts, oncologists, breast surgeons, breast care nurses, reproductive health specialists, psychologists, behavioural scientists, and consumers. The DA includes information concerning the pros and cons of fertility preservation in women with early breast cancer and has evidence-based representation of chances of success. It addresses the complexity, uncertain benefits and potentially large costs in this setting. A summary of treatment procedures are presented with a set of values clarification exercises to help weigh up the pros and cons of fertility preservation in light of patient values and life situation. The format of the DA will be a website. The DA will be provided to women after the completion of the baseline questionnaire.
Intervention code [1] 291840 0
Other interventions
Comparator / control treatment
A placebo controlled group will be used. This group will be directed to information already available about the impact of cancer treatment on fertility (Fertility Related Choices - BCNA Booklet).
Control group
Placebo

Outcomes
Primary outcome [1] 295037 0
The primary outcome is Decisional Conflict. This outcome is assessed by the Decisional Conflict Scale, a validated measure of decisional conflict.
Timepoint [1] 295037 0
Baseline (at time of recruitment), and one and 12 months after recruitment.
Secondary outcome [1] 314634 0
The secondary outcome is Knowledge - of cancer treatment and impact on fertility. This questionnaire was created for a previous DA study to assess current knowledge of cancer treatment and it's impact on fertility, and changes in knowledge over time.
Timepoint [1] 314634 0
Baseline (at time of recruitment), and one month, 6 months and 12 months after recruitment.
Secondary outcome [2] 314635 0
A secondary outcome is Decisional Regret. This outcome is assessed by the Decisional Regret Scale (DRS), a validated measure of decisional regret. The DRS will be administered twice to measure decisional regret related to a) fertility interventions, b) cancer treatments
Timepoint [2] 314635 0
DRS - fertility interventions administered one month, 6 months and 12 months after recruitment.
DRS - cancer treatments administered 6 months and 12 months after recruitment.
Secondary outcome [3] 314636 0
A secondary outcome is Informed Choice. This outcome is assessed by the Multi-dimensional Measure for Informed Choice, a validated measure of decision quality.
Timepoint [3] 314636 0
Baseline (at time of recruitment), and one month, 6 months and 12 months after recruitment.
Secondary outcome [4] 314637 0
A secondary outcome is Psychological Adjustment. This outcome is assessed by the Depression Anxiety Stress Scales (DASS 21), a validated measure of anxiety, depression and stress.
Timepoint [4] 314637 0
Baseline (at time of recruitment), and one month, 6 months and 12 months after recruitment.

Eligibility
Key inclusion criteria
To be eligible to participate women must:
a) be aged between 18-40 years (inclusive) at the time of diagnosis
b) histologically confirmed diagnosis of early-stage breast cancer
c) pre-menopausal at time of diagnosis,
d) have no history of metastatic disease prior to diagnosis,
e) interested in finding out more about fertility and/or fertility preservation at the time of diagnosis
f) able to give informed consent
g) have easy access to the internet
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Although women whose primary language is other than English (LOTE) will not explicitly be excluded, women will need to have enough English capability to complete the questionnaires and communicate with the researchers. Should the oncologist consider the patient’s English skills to be insufficient, they will be excluded.

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


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
15/01/2016
Actual
24/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 292014 0
Charities/Societies/Foundations
Name [1] 292014 0
National Breast Cancer Foundation
Country [1] 292014 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne, Parkville Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 290683 0
Hospital
Name [1] 290683 0
Royal Women's Hospital
Address [1] 290683 0
Flemington Rd, Parkville VIC 3052
Country [1] 290683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293503 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 293503 0
Level 6, East, 300 Grattan Street, Parkville Victoria 3052 Australia
Ethics committee country [1] 293503 0
Australia
Date submitted for ethics approval [1] 293503 0
14/09/2015
Approval date [1] 293503 0
05/10/2015
Ethics approval number [1] 293503 0

Summary
Brief summary
The primary purpose of this study is to develop and evaluate a new low literacy decision aid relating to fertility preservation for younger women with early stage breast cancer.

Who is it for?
You may be eligible to join this study if you are a pre-menopausal woman aged 18 to 40 years of age, who has been diagnosed with early stage breast cancer with no history of metastatic disease, and was interested in finding out more about fertility and/or fertility preservation at the time of diagnosis.

Study details
Participants in this study will be randomly selected (by chance) to receive either usual care or to access the decision aid website. The decision aid includes easy to understand information regarding the side effects of cancer treatments in terms of their effects on women's fertility, and options for preserving fertility to increase chances of having a baby at a later date.

Participants will then be asked to fill out a questionnaire before seeing the decision aid website, and also a questionnaire regarding the choices made and the use of the decision aid after one month, 6 months and again after one year.

It is hoped that the findings of this trial will provide information on how helpful fertility preservation information is to women with early stage breast cancer, and to improve access to this information by women as part of their medical care going forward.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57198 0
Dr Michelle Peate
Address 57198 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 57198 0
Australia
Phone 57198 0
+61 3 8345 3792
Fax 57198 0
Email 57198 0
[email protected]
Contact person for public queries
Name 57199 0
Dr Michelle Peate
Address 57199 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 57199 0
Australia
Phone 57199 0
+61 3 8345 3792
Fax 57199 0
Email 57199 0
[email protected]
Contact person for scientific queries
Name 57200 0
Dr Michelle Peate
Address 57200 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 57200 0
Australia
Phone 57200 0
+61 3 8345 3792
Fax 57200 0
Email 57200 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
At this stage there are no plans to share IPD


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.