Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000515897
Ethics application status
Approved
Date submitted
12/03/2021
Date registered
3/05/2021
Date last updated
17/06/2022
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating fertility decision aids for younger women with breast cancer.
Scientific title
Evaluating the impact of a fertility decision aid developed using health literacy principles, compared to a gold-standard decision aid, on decision-related outcomes in younger women with breast cancer.
Secondary ID [1] 303668 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Fertility Choices (FC)
Linked study record
This study is a follow-up study to a pilot study conducted in 2015-2019 – the aLLIAnCE (Low Literacy Decision Aid about Reproductive Choices for Younger Women with Breast Cancer) pilot study (ACTRN12615001364561).

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 321061 0
Low Health Literacy 321062 0
Decision-making 321063 0
Fertility Preservation 321064 0
Condition category
Condition code
Cancer 318869 318869 0 0
Breast
Reproductive Health and Childbirth 318870 318870 0 0
Fertility including in vitro fertilisation
Mental Health 318871 318871 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention - Fertility Choices website - is an online decision aid (DA) specifically adapted for inclusivity of a low health literacy audience using low health literacy principles, 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 is 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 is 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. Infographics and animations are also utilised to communicate topics and enhance understanding.

The DA website has been pilot-tested among 23 pre-menopausal women aged between 18-40 years (ACTRN12615001364561) who were previously diagnosed with early-stage breast cancer, and was reported to be acceptable, helpful and easy-to-understand. The DA was subsequently modified according to feedback from the pilot testing.

The updated DA website will be provided to women after completion of the baseline survey and randomisation. Each participant allocated to the DA website arm will receive an email/ letter with a link to access the website. Intervention adherence will be assessed by self-reported outcome, where patients will indicate if they have read the DA website (and how much of it) when completing the 1-Month survey.
Intervention code [1] 319968 0
Other interventions
Comparator / control treatment
The control is the Fertility-related choices DA booklet (current gold-standard) available on the Breast Cancer Network Australia (BCNA) website. This DA has been evaluated and shown to reduce decisional conflict and regret about fertility-related treatment options in young breast cancer patients. After completion of the baseline survey and randomisation, participants allocated to the control arm will receive the DA booklet attached to an email and a hard copy (if preferred) will be sent via express post.
Control group
Placebo

Outcomes
Primary outcome [1] 326815 0
Decisional conflict as assessed by the Decisional Conflict Scale (low literacy version), a validated measure of decisional uncertainty.
Timepoint [1] 326815 0
Baseline (at time of recruitment), 1 month, 6 months and 12 months after recruitment.
Secondary outcome [1] 392760 0
Decision Regret as assessed by the Decision Regret Scale, a validated measure of decision regret. The Decision Regret Scale will be used to quantify health care decision regret regarding (a) fertility treatment decisions, and (b) cancer treatment decisions.
Timepoint [1] 392760 0
1 month, 6 months and 12 months after recruitment.
Secondary outcome [2] 392761 0
Informed Choices as assessed by the Multidimensional Measure of Informed Choice – Attitudes subscale, a validated measure of decision quality.
Timepoint [2] 392761 0
Baseline (at time of recruitment), 1 month, 6 months and 12 months after recruitment.
Secondary outcome [3] 392762 0
Psychological outcomes as assessed by the Depression Anxiety Stress Scale, a validated measure of depression, anxiety and stress symptoms.
Timepoint [3] 392762 0
Baseline (at time of recruitment), 1 month, 6 months and 12 months after recruitment.
Secondary outcome [4] 394537 0
Knowledge of (i) assisted reproductive technologies; (ii) the impact of therapy regimens on fertility; and (iii) the impact of pregnancy after breast cancer on prognosis, as assessed by the Knowledge of Fertility-Related Information Scale. The survey items were selected based on previous research exploring the unmet fertility-related needs of this population and wording was adapted to be relevant to a low health literacy population.
Timepoint [4] 394537 0
Baseline (at time of recruitment), 1 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);
b) be pre-menopausal;
c) have a histologically confirmed diagnosis of early-stage breast cancer;
d) have no history of metastatic disease;
e) not have undergone adjuvant therapy for breast cancer;
f) have easy access to the internet;
g) have an interest in finding out more about fertility and/or fertility preservation;
h) be able to give informed consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have already started fertility preservation will be excluded.
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 surveys 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)
Randomisation is centralised and will be conducted through the secure software, Research Electronic Data Capture (REDCap) using a minimisation algorithm established by the study statisticians.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in REDCap using a minimisation algorithm (established by the study statistician), to aim for balance between the two study arms within clinic and within level of health literacy (low, not-low).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An effect size of 0.4 discriminates between those who make and those who delay decisions, based on the Decisional Conflict literature. A total sample size of 200 patient participants will allow an effect size (i.e. standardised difference) of 0.4 in Decisional Conflict Score between the tool and booklet at 12 months to be detected with 80% power at 2-sided significance 0.05 level, assuming equal standard deviations in both groups and no correlation between baseline and 12-month measures (conservative). We aim to recruit 236 (118 per arm) patient participants by taking account of an expected approx. 15% drop out rate.

All data analyses will be undertaken on an intention-to-treat approach. Continuous outcomes will be measured by mixed-model repeated measures analyses; binary outcomes will be analysed using a repeated measures logistics regression model. Heterogeneity in group effect will also be explored for the following subgroups: health-literacy (low, not low), parity (children, no children), partners (in a committed relationship, not in a committed relationship), training in allied health (yes, no) and education level (high school, certificate/ diploma, undergraduate, postgraduate degree).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 308087 0
Charities/Societies/Foundations
Name [1] 308087 0
National Breast Cancer Foundation
Country [1] 308087 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne, Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 308830 0
None
Name [1] 308830 0
Address [1] 308830 0
Country [1] 308830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308073 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 308073 0
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 308073 0
Australia
Date submitted for ethics approval [1] 308073 0
23/02/2021
Approval date [1] 308073 0
28/05/2021
Ethics approval number [1] 308073 0
HREC/72706/MH-2021

Summary
Brief summary
This study aims to evaluate the impact of an online low health literacy fertility-related decision aid (DA) for young women with early breast cancer among women of all health literacy levels. The primary hypothesis is that the Intervention (DA website) is superior to the control (DA booklet), as measured by a greater reduction in decisional conflict at 12 months via the Decisional Conflict Scale.

Who is it for?
You may be eligible to take part in this study if you are a pre-menopausal woman aged between 18-40 years, have recently been diagnosed with early stage breast cancer, have not had an advanced cancer, have not undergone adjuvant therapy for breast cancer, want to find out more about fertility and/or fertility preservation at the time of diagnosis, and have easy access to the internet.

Study details
Participants will be randomly allocated (by chance) to receive either the new decision aid website or the existing decision aid booklet. The decision aid website contains easy-to-understand information about the side effects of cancer treatments on women's fertility, and options for preserving fertility to increase the chances of having a baby in the future.

Participants will be asked to complete surveys at 4 timepoints: baseline (before viewing the DA), 1-month, 6-months, and 12-months after recruitment. We will then assess how effective the new DA is in supporting women to make decisions about breast cancer treatment and fertility. It is hoped that the DA will lead to better understanding of fertility-related issues and educated involvement in decision-making among women with diverse levels of health literacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109434 0
Dr Michelle Peate
Address 109434 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 109434 0
Australia
Phone 109434 0
+61 3 8345 3792
Fax 109434 0
+61 3 8345 3702
Email 109434 0
mpeate@unimelb.edu.au
Contact person for public queries
Name 109435 0
Dr Michelle Peate
Address 109435 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 109435 0
Australia
Phone 109435 0
+61 3 8345 3792
Fax 109435 0
+61 3 8345 3702
Email 109435 0
mpeate@unimelb.edu.au
Contact person for scientific queries
Name 109436 0
Dr Michelle Peate
Address 109436 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 109436 0
Australia
Phone 109436 0
+61 3 8345 3792
Fax 109436 0
+61 3 8345 3702
Email 109436 0
mpeate@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans to share IPD at this stage.


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.