Support, Positioning and Organ Registration during breast cancer Radiation Therapy: SuPPORT 4 All

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN84236905
• Date of registration: 27/09/2011
• Prospective Registration: No
• Primary sponsor: Sheffield Teaching Hospitals NHS Trust
• Public title: Support, Positioning and Organ Registration during breast cancer Radiation Therapy: SuPPORT 4 All
• Scientific title: Support, Positioning and Organ Registration during breast cancer Radiation Therapy: a Phase I study
• Date of first enrolment: 01/08/2011
• Target sample size: 41
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN84236905
• Study type: Observational
• Study design: Non-randomised trial (Treatment)
• Phase: Phase I

Countries of recruitment

United Kingdom

Contacts

• Name: Heidi Probst

Key inclusion & exclusion 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: User focus groups:
1. Patients who have undergone a mastectomy
2. Patients with known metastasis
3. Patients unable to give informed consent

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer
Cancer
Malignant neoplasm of breast

Intervention(s)

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 phase I (modelling) stages of the MRC framework. This phase includes a systematic review of the literature on available methods of immobilisation for breast irradiation, followed by qualitative data collection using focus groupswith breast cancer patients, one to one interviews with Oncologists and physicists and online blog discussions with therapy radiographers (radiation therapists). In addition, this phase includes physics testing of a range of materials on a linear accelerator to assess the suitability of materials to be used in the production of a prototype support device.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

10524

Source(s) of Monetary Support

Engineering and Physical Sciences Research Council (EPSRC)