None listed
Conditions
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.
Interventions
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 informa
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.)
Sponsors
Dr Kerry Sherman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed