Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000363280
Ethics application status
Approved
Date submitted
4/03/2009
Date registered
26/05/2009
Date last updated
17/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an online decision aid for women considering breast reconstruction following mastectomy
Scientific title
Randomised trial among women recently diagnosed with breast cancer, or with genetic breast cancer susceptibility, to evaluate the impact of the Breast RECONstruction Decision Aid (BRECONDA), an online decision aid for women considering breast reconstruction following mastectomy, compared with usual care, and its impact on decisional conflict/regret, satisfaction with information and breast reconstruction knowledge.
Secondary ID [1] 280020 0
There is no other ID for this study
Universal Trial Number (UTN)
Trial acronym
BRECONDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 4414 0
Condition category
Condition code
Cancer 4676 4676 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NOTE: Women who identified as being recently diagnosed for breast cancer (but not at increased risk for hereditary breast cancer) were included in the first arm of this RCT labelled as ‘Main study (study 1)’ throughout this document. Women who identified as being at increased risk for hereditary breast cancer were included in a second arm of this RCT labelled as ‘Genetics study (study 2)’ throughout this document.

Breconda: Breast reconstruction decision aid, which contains modules with information related to breast reconstruction and tips for participants in making their decision and coping strategies.

Main study (study 1): Breconda is administered to participants in this study following a breast cancer diagnosis, before reconstructive surgery.

Genetics study (study 2): Breconda is administered to participants in this study who underwent BRCA1/2 testing and who were contemplating risk reducing mastectomy surgery, (i.e., before mastectomy and reconstructive surgery.)
Intervention code [1] 4154 0
Behaviour
Comparator / control treatment
Participants in the control group will receive usual care which entails the provision of basic information about breast surgery and options for surgery via online brochures.

Main study (study 1): This information is administered to participants in this study following a breast cancer diagnosis, before reconstructive surgery.

Genetics study (study 2): This information is administered to participants in this study who underwent BRCA1/2 testing and who were contemplating risk reducing mastectomy surgery, (i.e., before mastectomy and reconstructive surgery.)
Control group
Active

Outcomes
Primary outcome [1] 5539 0
Decisional conflict - Decisional Conflict Scale
Timepoint [1] 5539 0
Main study (study 1): Baseline prior to breast reconstructive surgery, then 1 and 6 months after the completion of the first Decisional Conflict Scale.

Genetics study (study 2): Baseline prior to any breast reconstructive surgery, then 2 months after the completion of the first Decisional Conflict Scale.
Primary outcome [2] 5540 0
Decisional regret - Decisional regret scale
Timepoint [2] 5540 0
Main study (study 1): 1 and 6 months after the completion of the first Decisional Regret Scale.

Genetics study (study 2): This long-term outcome was not measured for the genetic component of the RCT as these women were not expected to have made a surgical decision within the study’s timeframe.
Primary outcome [3] 5541 0
Satisfaction with information - Satisfaction with Information Scale.
Timepoint [3] 5541 0
Main study (study 1): Baseline prior to breast reconstructive surgery, then 1 and 6 months after the completion of the first Satisfaction with Information Scale.

Genetics study (study 2): Baseline prior to any breast reconstructive surgery, then 2 months after the completion of the first Satisfaction with Information Scale.
Secondary outcome [1] 9336 0
Quality of Life - FactB
Timepoint [1] 9336 0
Main study (study 1): Baseline prior to breast reconstructive surgery, then 1 and 6 months after the completion of the first Quality of Life Scale.

Genetic study (study 2): This outcome was not assessed in the genetic component of this RCT.
Secondary outcome [2] 319616 0
Knowledge about breast reconstruction - five true/false statements used in prior research
Timepoint [2] 319616 0
Main study (study 1): Baseline, then 1 and 6 months after the completion of the first Knowledge Scale.

Genetic study (study 2): Baseline, then 2 months after the completion of the first Knowledge Scale.

Eligibility
Key inclusion criteria
Main study (study 1): Women recently diagnosed with breast cancer; over 18 years; likely to have a mastectomy and candidate for breast reconstruction; basic computer skills (able to use a mouse); access to an online computer; resident in Australia. Since, for some women, mastectomy is optional and information about breast reconstruction plays an important role in deciding whether or not to have a mastectomy, women who are considering having a mastectomy are also eligible.

Genetics study (study 2): Women at increased risk of developing hereditary breast cancer; over 18 years; likely to have a mastectomy and candidate for breast reconstruction; basic computer skills (able to use a mouse); access to an online computer; resident in Australia. Since, for some women, mastectomy is optional and information about breast reconstruction plays an important role in deciding whether or not to have a mastectomy, women who are considering having a mastectomy are also eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Main study (study 1) and Genetics study (study 2): Insufficient mastery of the English language to complete study questionnaires and read study material

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)
Main study (study 1) and Genetics study (study 2): This study will be conducted online. All participants will register for the study in a secure environment and receive a unique login and password for the duration of the study. Once the baseline questionnaire is submitted online, the participant will be automatically randomised to one of the two study conditions. The randomisation procedure is blinded in that neither clinic staff nor researchers will be aware to which condition a participant has been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Main study (study 1) and Genetics study (study 2): A randomised sequence will be generated from Randomisation.com. Participants will be allocated to the conditions automatically according to this randomisation schedule.
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
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
7/12/2011
Date of last participant enrolment
Anticipated
Actual
10/01/2014
Date of last data collection
Anticipated
Actual
25/01/2015
Sample size
Target
234
Accrual to date
Final
352
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 1528 0
2145
Recruitment postcode(s) [2] 1529 0
2750

Funding & Sponsors
Funding source category [1] 4602 0
Government body
Name [1] 4602 0
Cancer Australia and National Breast Cancer Foundation
Country [1] 4602 0
Australia
Primary sponsor type
Individual
Name
Dr Kerry Sherman
Address
Department of Psychology
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 4151 0
Hospital
Name [1] 4151 0
NSW Breast Cancer Institute
Address [1] 4151 0
Westmead Hospital
Westmead NSW 2145
Country [1] 4151 0
Australia
Other collaborator category [1] 597 0
Individual
Name [1] 597 0
Dr Diana Harcourt
Address [1] 597 0
Centre for Appearance Research
University of West of England
Bristol
Country [1] 597 0
United Kingdom
Other collaborator category [2] 598 0
Individual
Name [2] 598 0
Associate Professor John Boyages
Address [2] 598 0
Executive Director
NSW Breast Cancer Institute
Westmead Hospital, Westmead NSW 2145
Country [2] 598 0
Australia
Other collaborator category [3] 599 0
Individual
Name [3] 599 0
Dr Thomas Lam
Address [3] 599 0
NSW Breast Cancer Institute
Westmead Hospital
Westmead NSW 2145
Country [3] 599 0
Australia
Other collaborator category [4] 600 0
Individual
Name [4] 600 0
Dr Paul Brown
Address [4] 600 0
Health Systems and Centre for Health Services Research and Policy (CHSRP)
School of Population Health
University of Auckland
Country [4] 600 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6647 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 6647 0
Westmead Hospital
Westmead NSW 2145
Ethics committee country [1] 6647 0
Australia
Date submitted for ethics approval [1] 6647 0
Approval date [1] 6647 0
10/12/2007
Ethics approval number [1] 6647 0
HREC2007/5/4.10(2600)

Summary
Brief summary
Main study (study 1):
This study evaluates the effectiveness of an online decision aid for women considering breast reconstruction following mastectomy.
Who is it for?
You can join this study if you are a woman over 18 years who:
- Has recently been diagnosed with breast cancer
- Is a candidate for mastectomy and breast reconstruction
- Has basic computer skills and access to an online computer
Trial details:
Participants will be randomly divided into two groups. Participants in both groups will receive standard care which involves the provision of basic information about breast surgery and options for surgery. Participants in one group will also have access to an online decision aid tool, Breconda, to assist in their decision making.
The aim of this study is to determine the effectiveness of the online decision aid tool in helping women make a decision they are happy with according to a scale that measures decisional conflict and regret scales.

Genetic study (study 2):
This study evaluates the effectiveness of an online decision aid for women at increased risk for hereditary breast cancer.
Who is it for?
You can join this study if you are a woman over 18 years who:
- Is undergoing genetic testing for hereditary breast cancer
- Is a possible candidate for risk-reducing mastectomy and breast reconstruction
- Has basic computer skills and access to an online computer
Trial details:
Participants will be randomly divided into two groups. Participants in both groups will receive standard care which involves the provision of basic information about breast surgery and options for surgery. Participants in one group will also have access to an online decision aid tool, Breconda, to assist in their decision making.
The aim of this study is to determine the effectiveness of the online decision aid tool in helping women make a decision they are happy with according to a scale that measures decisional conflict and regret scales.
Trial website
Trial related presentations / publications
Sherman, K.A. Shaw, L-K., Winch, C., Harcourt, D., Cameron, L., & Brown, P. (2015). Psychological distress, age and salience of physical appearance: Mediator and moderator effects of the BRECONDA web-based decision aid for women considering breast reconstruction following mastectomy. Oral presentation at the 2015 World Congress of Psycho-Oncology and Psychosocial Academy Workshops. Washington, July 28-August 1.
Sherman, K.A., Harcourt, D., Shaw, LK, Winch, C., Lam, T., Boyages, J., Brown, P., Cameron, L.D. (2014). The BRECONDA trial: Facilitating surgical decision making of women with breast cancer. Paper presented at the 13th International Congress of Behavioral Medicine, 20-23 August 2014, Groningen, Netherlands.
Sherman, K., Harcourt, D., Lam, T., Boyages, J., Brown, P., Cameron, L., Shaw, L-K, Winch, C. & the BRECONDA project Collaborative Group (2014). Assisting women with breast cancer make surgical decisions: Results from a RCT of the BRECONDA web-based decision aid. Paper presented at the Australasian Society for Behavioural Health and Medicine 11th Annual Scientific Conference, 12 – 14th February 2014, Auckland, New Zealand.
Sherman, K., Harcourt, D., Lam, T., Shaw, LK., & Winch, C. (2013). Facilitating decision making of women considering breast reconstruction following mastectomy: Results from a randomised controlled trial of the BRECONDA web-based decision aid. Paper presented at the IPOS 15th World Congress of Psycho-Oncology, Rotterdam, the Netherlands, 4-8th November.
Public notes

Contacts
Principal investigator
Name 29345 0
A/Prof Kerry Sherman
Address 29345 0
Level 7, C3A Building
Department of Psychology
Macquarie University,
NSW 2109, Australia
Country 29345 0
Australia
Phone 29345 0
+61 2 9850 6874
Fax 29345 0
Email 29345 0
[email protected]
Contact person for public queries
Name 12592 0
A/Prof Dr Kerry Sherman
Address 12592 0
Department of Psychology,
Macquarie University NSW 2109
Country 12592 0
Australia
Phone 12592 0
+61 2 9850 6874
Fax 12592 0
+ 61 2 9850 8062
Email 12592 0
[email protected]
Contact person for scientific queries
Name 3520 0
A/Prof Dr Kerry Sherman
Address 3520 0
Department of Psychology,
Macquarie University NSW 2109
Country 3520 0
Australia
Phone 3520 0
+61 2 9850 6874
Fax 3520 0
+61 2 9850 8062
Email 3520 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
SourceTitleYear of PublicationDOI
EmbaseFacilitating decision-making in women undergoing genetic testing for hereditary breast cancer: BRECONDA randomized controlled trial results.2017https://dx.doi.org/10.1016/j.breast.2017.10.001
N.B. These documents automatically identified may not have been verified by the study sponsor.