A decision explorer for women deciding about breast cancer treatments

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast; Cancer; Breast cancer

• Registration Number: ISRCTN18709765
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22541508

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-03-31
• Study Start: 2010-04-29
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 148

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).
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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified