A novel carbon-fibre adjustable reusable accessory (CARA) for supine breast positioning to reduce toxicity in breast adjuvant radiotherapy: a study protocol for a multicentre phase III randomized controlled trial

Table 1 Schedule of activities and data collection

Study Activity	New patient appointment with radiation oncologist	Prior to CT simulation	Prior to first treatment	Weekly during Breast RT	Post-RT weekly to 7 weeks from start of breast RT
Introduction to study	X
Inclusion/exclusion criteria screening	X	X
Informed consent obtained		X
Enrollment and randomization		X
Baseline assessment			X
Patient-reported outcome questionnaire			X	X	X
Skin assessment performed by staff			X	Last week of RT, or for five-day fractionation, last day of RT	Optional per patient preference
Skin dose measurement				Up to three times per patient; optional for sites other than the coordinating site
Timing of clinical flow				X
Standard imaging				X
CBCT imaging				Up to three times per patient
Therapist satisfaction				Last week of RT, or for five-day fractionation, last day of RT

ISSN: 1471-2407