A support bra to improve accuracy of radiation therapy for women having treatment to the breast

ISRCTN	ISRCTN38272993
DOI	https://doi.org/10.1186/ISRCTN38272993
Secondary identifying numbers	34420

Submission date: 24/04/2017
Registration date: 24/04/2017
Last edited: 10/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-about-the-s4a-support-bra-for-women-having-radiotherapy-for-breast-cancer

Study website

Contact information

Prof Heidi Probst
Public

Sheffield Hallam University
Robert Winston Building
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom

ORCID ID	0000-0003-0035-1946
Phone	+44 1142 254359
Email	h.probst@shu.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment, Device
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Support, Positioning and Organ stabilisation during Breast Cancer Radiation Therapy: The SuPPORT 4 All project
Study acronym	SuPPORT 4 All
Study hypothesis	The aim of this study is to test how practical it is for women to wear the S4A bra during radiotherapy, and how easy it is for the radiographers to use the bra to help them position the patient underneath the radiotherapy machine each day.
Ethics approval(s)	17/NW/0236
Condition	Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast
Intervention	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 study-co-ordinator (who will not be directly involved in recruiting patients to the study). Intervention group: Participants receive breast radiotherapy with S4A bra with one tattoo. This involves standard radiotherapy to the breast with patients planned and treated in the S4A bra with a single anterior permanent tattoo placed on the midline according to normal practice for breast irradiation. Patients will receive a standard radiotherapy dose of 40Gy in 15 fractions (daily over three weeks). Control group: Participants receive their existing radiotherapy with standard set-up with no immobilisation with tattoos. This involves patients being planned for breast irradiation and treated as per standard practice with three permanent tattoos place on the torso one anteriorly on the midline and one either side of the thorax. Patients in the control group will be treated to the standard radiotherapy dose of 40Gy in 15 fractions (daily over three weeks). Follow up involves completion of a postal questionnaire at 7 weeks (body image questionnaire, skin and breast changes self assessment, and patient empowerment questionnaire) and a final postal questionnaire at 3 months to assess body image. (details of other outcomes measured during treatment are listed in the outcome section).
Intervention type	Other
Primary outcome measure	Feasibility of recruitment to main trial is defined as recruitment of 50 participants recruited in a six-month recruitment window at one centre.
Secondary outcome measures	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. Patient comfort measured by a comfort questionnaire developed from interviews with healthy volunteers that have tried the support bra and adaptations of the Kolcaba patient comfort questionnaire for radiotherapy patients, measured at baseline (at the time of fitting during radiotherapy planning) and weeks 1, 2 and 3 of treatment 5. Patient modesty measured by the patient modesty scale and a newly developed story board of the radiotherapy journey to measure patient experiences of physical exposure at weeks 1, and 3 of treatment 6. Patient empowerment using the 28-item patient empowerment scale for cancer patients, measured at baseline and weeks 1, 2, 3 and 7 of radiotherapy 7. • Body Image using the 10-item body image scale, measured at baseline and at 3 weeks, week 7 (one month post treatment) and 3 months
Overall study start date	02/01/2016
Overall study end date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
Participant 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)
Participant 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.
Recruitment start date	22/05/2017
Recruitment end date	31/01/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Weston Park Hospital

Whitham Road
Sheffield
S10 2SJ
United Kingdom

Sponsor information

Sheffield Hallam University
University/education

Howard Street
City Campus
Sheffield
S1 1WB
England
United Kingdom

Phone	+44 114 225 4050
Email	researchsupport@shu.ac.uk
"ROR"	https://ror.org/019wt1929

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	1. Conference presentation -ESTRO European Society for Radiation Oncology 2. Publication of the clinical test outcomes in either International Journal of Radiation Oncology Biology Physics or Radiotherapy and Oncology or Clinical Oncology journal 3. Dissemination of outcomes via established networks including patient groups Breast Cancer Care, Breast Radiotherapy Interest Group, UK Radiotherapy Managers group, College of Radiographers Research network and CTRad (radiotherapy research network supported by the NCRI) 4. Study outcomes as open educational resources shared via established radiotherapy networks 5. Presentation at the national radiotherapy managers group 6. Press release on project outcomes
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		04/05/2021	05/05/2021	No	No
Plain English results		20/10/2021	20/10/2021	No	Yes
Protocol file	version 4	01/08/2018	10/10/2022	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN38272993_BasicResults_04May2021.docx: uploaded 05/05/2021
ISRCTN38272993_Protocol_v4_01Aug2018_.pdf

Editorial Notes

10/10/2022: Protocol file uploaded.
20/10/2021: The Cancer Research UK lay results summary has been added.
05/05/2021: The basic results have been uploaded as an additional file.
15/01/2019: The intention to publish date has been changed from 30/12/2018 to 30/09/2019.
14/01/2019: The following changes have been made:
1. The overall end date has been changed from 01/01/2018 to 30/04/2019.
2. The recruitment end date has been changed from 29/09/2017 to 31/01/2019.
16/01/2018: Cancer Help UK lay summary link added to plain English summary field
16/10/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
25/04/2017: Study information verified with principal investigator.