Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The study follows the framework proposed by the Medical Research Council (MRC) for randomised controlled trials for complex interventions. This current phase reflects the pre-clinical (theory) and pha
Sponsors
Sheffield Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The patient focus groups will include consenting patients that meet the following criteria: 1. Have completed (or completing) a course of adjuvant radiotherapy for early stage breast cancer 2. Have undergone a wide local excision 3. Able to speak and understand English (for the purposes of the focus groups it is important to include users from a range of socioeconomic and ethnic backgrounds, although having individuals who can speak and understand English will allow facilitation of discussions) 4. Female patients only, as the focus of this study is about immobilising mobile breast tissue following a wide local excision of a breast tumour 5. Age > 18 years To gather product specification data from health professionals a purposive sample will be chosen from professionals who have specialist knowledge of breast irradiation. It is anticipated that this will consist of a range of professionals from the following disciplines: 1. Clinical Oncologists specialising in breast cancer 2. Radiation Therapists specialising in breast cancer 3. Dosimetrists or Medical Physicists with expertise in breast radiotherapy planning Health care professional (HCP): 1. Completed basic training 2. Have recent experience of treating (or planning) breast cancer radiotherapy (i.e. in the last 3 years) 3. Minimum 18 years of age 4. Male or female
Exclusion criteria
Exclusion criteria: User focus groups: 1. Patients who have undergone a mastectomy 2. Patients with known metastasis 3. Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The identification of an immobilisation method, an appropriate material for immobilisation and a suitable method for positional registration. The timepoint for this primary end point is November 2011 determined by evidence from the literature, the analysis of the qualitative data from stakeholders and the surface dose measurements taken from the material testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| The development of a specification for the support bra. The timepoint for this endpoint is the end of November 2011 and will be determined by the analysis of the qualitative data from stakeholders. | — |
Countries
United Kingdom
Outcome results
None listed