A decision explorer for women deciding about breast cancer treatments
| ISRCTN | ISRCTN18709765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18709765 |
| Secondary identifying numbers | 4261 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 25/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Stephanie Sivell
Scientific
Scientific
Department of Primary Care and Public Health
Centre for Health Sciences Research
3rd Floor, Neuadd Meirionnydd, Heath Park
Cardiff
CF14 4XN
United Kingdom
Study information
| Study design | Non-randomised interventional and observational trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A decision explorer for women deciding about breast cancer treatments: BresDex trial |
| Study acronym | BresDex |
| Study objectives | Women who have breast cancer often have a choice of operations, the most common include either mastectomy or breast conservation surgery followed by radiotherapy. Women faced with such choices need clear, accurate information about what the treatments involve and how they differ. They also need to be able to think about how they feel about these options, so they can make a choice that is best for them. Equivalent survival data have led to an assumed view that women, if offered a choice, would choose to have breast conservation surgery. However, studies reveal national and international variation in surgical practice in this area. Our research highlights the importance of addressing treatment expectations and preferences of both patients and professionals. Experience in other areas demonstrate patient decision support tools (aids) can be useful where difficult decisions exist. At present, such tools are not available for the UK context. These tools help people make informed choices, consistent with their views and values, and support them to the extent they need. Such tools are an important extension of the information giving that is currently available, but does not replace the vital contact between patient and professionals. We propose to develop, validate, field test, and evaluate the impact of an interactive decision explorer in helping UK women make decisions about treatment after they have been told they have early breast cancer. |
| Ethics approval(s) | MREC for Wales approved on the 5th February 2007 (ref: 07/MRE09/3) |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | Internet bases decision aid/explorer called BresDex. BresDex is designed to support women diagnosed with early breast cancer who do not have to have a mastectomy, but instead have the option of a wide local excision. This support is to be provided as an adjunct to the help and support women currently receive from their clincial teams. |
| Intervention type | Other |
| Primary outcome measure | Online quantitative study which looks at how patients use BresDex |
| Secondary outcome measures | A qualitative study exploring patients reactions to BresDex while facing this decision. |
| Overall study start date | 03/12/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 148 |
| Key inclusion criteria | Patient needs assessment: 1. Women diagnosed as having early breast cancer within 3 to 6 months of their 1st therapeutic treatment 2. Given an option of either breast conservation surgery or mastectomy Professional needs assessment: Data will be collected from a purposive sample of NHS based individuals recruited to represent a number of multidisciplinary breast teams and their constituent members; breast surgeons, breast care nurses, breast oncologists, opinion leaders with expertise in the surgical, oncological and psycho-oncological perspectives of breast cancer management including a representative of the Association of Breast Surgeons at the British Association of Surgical Oncology (BASO). Inclusion criteria: 1. Willingness to be interviewed about this area of clinical practice 2. Experience of directly dealing with women facing treatment decisions for early breast cancer Prototype development: 1. Women (any age) diagnosed as having early breast cancer (stage 1) 2. Given an option of either breast conservation surgery or mastectomy 3. Within 3 to 6 months of their first therapeutic treatment External key informants including the health care professionals identified and consented in Step 3 and those nominated by the Study Management Group who agree to provide formative advice will also be consulted during the prototype development. These key informants must show a willingness to participate in the development and evaluation of a prototype of the decision explorer. Evaluation of completed decision explorer: 1. Women (any age) diagnosed as having early breast cancer (stage 1 and 2) 2. Surgical treatment options |
| Key exclusion criteria | Patient needs assessment: 1. Women beyond 6 months of their initial therapeutic treatment who have chosen to undergo either breast conservation surgery or mastectomy 2. Women recently diagnosed with breast cancer who were not given surgical treatment options 3. Any conditions or illness that preclude the completion of a semi-structured interview about the issue of breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis 4. Any conditions precluding the ability to give informed consent to participate in the study Professional needs assessment: 1. For the sample of NHS-based multidisciplinary team members, health care professionals who are not permanent specialist members of specialist multidisciplinary breast team 2. Individuals not routinely involved in discussing treatment options with patients newly diagnosed with breast cancer Prototype development: 1. Women beyond 6 months of their initial therapeutic treatment who have chosen to undergo either breast conservation surgery or mastectomy 2. Women recently diagnosed with breast cancer who were not given surgical treatment options 3. Any conditions or illness that preclude the completion of a semi-structured interview about the issue of breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis 4. Any conditions precluding the ability to give informed consent to participate in the study Evaluation of completed decision explorer: 1. Women beyond their initial therapeutic surgical treatment who have chosen to undergo either breast conservation surgery or mastectomy 2. Women recently diagnosed with breast cancer who were not given surgical treatment options 3. Any conditions or illness that preclude the completion of a semi-structured interview about the consideration of treatment choices for early breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis 4. Conditions precluding the ability to give informed consent to participate in the study 5. Health care professionals who are not involved in the care and therefore the recruitment of patients asked to use the decision explorer in this step |
| Date of first enrolment | 03/12/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
Research and Commercial Division
7th Floor, 30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Website | http://www.cardiff.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C6475)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
Editorial Notes
25/02/2019: The trial website link has been deleted.
12/12/2017: Publication reference added.
