Specialty: Cancer, Primary sub-specialty: Breast Cancer
Conditions
Interventions
Patients will be randomised 1:1 to one of two groups. Randomisation will be through block randomisation (with blocks an integer multiple of four)
stratified by breast/bra cup size (S4A bra size 3-7 vs. S4A bra size 8-12). The trial statistician will generate a randomisation schedule using existing software. This will be held remotely by the stu
Sponsors
Sheffield Hallam University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Have undergone conservative surgery leaving an intact breast. 3. Invasive carcinoma of the breast 4. pT1-3, pN0-1, M0 disease 5. Referred for whole breast radiotherapy only 6. Able to give written informed consent. 7. A bra cup size that fits in the S4A bra size 3 and above (i.e. 28F/30E/32DD/34D/36C and above)
Exclusion criteria
Exclusion criteria: 1. Previous ipsilateral or contralateral breast cancer (including DCIS). 2. Concurrent cytotoxic chemotherapy, (sequential adjuvant chemotherapy is allowed). 3. Radiotherapy to regional lymph nodes. 4. Requires a radiotherapy boost to the site of the primary tumour bed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment to main trial is defined as recruitment of 50 participants recruited in a six-month recruitment window at one centre. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility outcomes 1. Recruitment and attrition rates (CONSORT data): number of patients assessed for eligibility; reasons for exclusion, numbers discontinuing intervention (with reasons), numbers analysed and excluded from the analysis 2. Number of missing values/incomplete cases is measured by reviewing study data at endline 3. Intervention adherence: Defined objectively as the number of radiotherapy fractions where the bra is used (for the intervention group) divided by the number of fractions prescribed 4. Intervention fidelity: During the study period site observations will be undertaken of treatment set-up for patients in both the control and intervention arms to ensure the support bra is used and positioned correctly and technique protocols are used in a standard manner across intervention and control groups 5. Technology acceptance from both healthcare practitioners and patients using an adapted Technology Acceptance Tool (based on the Technology Acceptance Model) at baseline 6. Feasibility of recruiting future participating centres: target sites for the main study will be screened for suitability, by interviewing potential principal investigators The following outcome measures will be assessed for suitability to be used in the main trial: 1. Skin reactions using the Radiation Therapy and Oncology Group skin scoring assessment (RTOG) both staff scored and patient self –reported using a new lay reporting skin assessment tool. Measured at baseline and weekly while on treatment then at four weeks post treatment. 2. Dose to organs at risk, including mean ipsilateral lung dose, and mean heart dose (for those treated for a left breast cancer) measured from the radiotherapy treatment plan 3. Incidence of moist desquamation in the inframammary fold at week 3 of radiotherapy 4. Pat | — |
Countries
England, United Kingdom
Contacts
Public ContactHeidi Probst
Outcome results
None listed