Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bresdex.com

Contact information

Type

Scientific

Primary contact

Ms Stephanie Sivell

ORCID ID

Contact details

Department of Primary Care and Public Health
Centre for Health Sciences Research
3rd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4261

Study information

Scientific title

A decision explorer for women deciding about breast cancer treatments: BresDex trial

Acronym

BresDex

Study hypothesis

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

MREC for Wales approved on the 5th February 2007 (ref: 07/MRE09/3)

Study design

Non-randomised interventional and observational trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/12/2007

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 148

Participant 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

Recruitment start date

03/12/2007

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
7th Floor
30 - 36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C6475)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes