Condition category
Cancer
Date applied
24/04/2017
Date assigned
24/04/2017
Last edited
15/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

www.support4all.org.uk

Contact information

Type

Public

Primary contact

Prof Heidi Probst

ORCID ID

http://orcid.org/0000-0003-0035-1946

Contact details

Sheffield Hallam University
Robert Winston Building
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom
+44 1142 254359
h.probst@shu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34420

Study information

Scientific title

Support, Positioning and Organ stabilisation during Breast Cancer Radiation Therapy: The SuPPORT 4 All project

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

17/NW/0236

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

02/01/2016

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

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

29/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Sponsor information

Organisation

Sheffield Hallam University

Sponsor details

Howard Street
City Campus
Sheffield
S1 1WB
United Kingdom
+44 114 225 4050
researchsupport@shu.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

30/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/09/2017: Internal review. 06/06/2017: Internal review. 25/04/2017: Study information verified with principal investigator.