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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]

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

Condition category

Condition code

Cancer

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]

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]

Decisional conflict - Decisional Conflict Scale

Timepoint [1]

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]

Decisional regret - Decisional regret scale

Timepoint [2]

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]

Satisfaction with information - Satisfaction with Information Scale.

Timepoint [3]

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]

Quality of Life - FactB

Timepoint [1]

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]

Knowledge about breast reconstruction - five true/false statements used in prior research

Timepoint [2]

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?

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]

2145

Recruitment postcode(s) [2]

2750

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Cancer Australia and National Breast Cancer Foundation

Address [1]

Ground Floor, Block B
Penrhyn House
Bowes Street
Woden ACT 2602

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Kerry Sherman

Address

Department of Psychology
Macquarie University NSW 2109

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

NSW Breast Cancer Institute

Address [1]

Westmead Hospital
Westmead NSW 2145

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Diana Harcourt

Address [1]

Centre for Appearance Research
University of West of England
Bristol

Country [1]

United Kingdom

Other collaborator category [2]

Individual

Name [2]

Associate Professor John Boyages

Address [2]

Executive Director
NSW Breast Cancer Institute
Westmead Hospital, Westmead NSW 2145

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Thomas Lam

Address [3]

NSW Breast Cancer Institute
Westmead Hospital
Westmead NSW 2145

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Paul Brown

Address [4]

Health Systems and Centre for Health Services Research and Policy (CHSRP)
School of Population Health
University of Auckland

Country [4]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service Human Research Ethics Committee

Ethics committee address [1]

Westmead Hospital 
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/12/2007

Ethics approval number [1]

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

A/Prof Kerry Sherman

Address

Level 7, C3A Building
Department of Psychology
Macquarie University,
NSW 2109, Australia

Country

Australia

Phone

+61 2 9850 6874

Fax

kerry.sherman@mq.edu.au

Contact person for public queries

Name

Dr Kerry Sherman

Address

Department of Psychology,
Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 6874

Fax

+ 61 2 9850 8062

kerry.sherman@mq.edu.au

Contact person for scientific queries

Name

Dr Kerry Sherman

Address

Department of Psychology,
Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 6874

Fax

+61 2 9850 8062

kerry.sherman@mq.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Facilitating decision-making in women undergoing genetic testing for hereditary breast cancer: BRECONDA randomized controlled trial results.	2017	https://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.

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Documents added automatically