Exercise to prevent shoulder problems in patients undergoing breast cancer treatment
| ISRCTN | ISRCTN35358984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35358984 |
| Secondary identifying numbers | HTA 13/84/10 |
- Submission date
- 23/01/2015
- Registration date
- 04/02/2015
- Last edited
- 02/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Contact information
Public
Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 551722 |
|---|---|
| prosper@warwick.ac.uk |
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0002-8462-7999 |
|---|---|
| Phone | +44 (0)2476 151128 |
| julie.bruce@warwick.ac.uk |
Study information
| Study design | Multicentre randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The PRevention Of Shoulder ProblEms Study (PROSPER): a randomised controlled clinical trial comparing physiotherapy-led exercise versus usual care in women at high risk of shoulder problems after breast cancer surgery |
| Study acronym | PROSPER |
| Study hypothesis | The hypothesis for the study is that an early supervised exercise programme delivered to women at high risk of subsequent shoulder problems after breast cancer surgery, can improve upper arm function and health-related quality of life, reduce disability, pain and other adverse events, 12 months after treatment. The overall aim of the study is to investigate the clinical and cost-effectiveness of early supervised exercise compared to usual care, on outcomes of shoulder/arm function, chronic pain and health-related quality of life after treatment for breast cancer. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/138410 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/136999/PRO-13-84-10.pdf |
| Ethics approval(s) | West Midlands – Solihull Research Ethics Committee, 20/07/2015, ref: 15/WM/0224 |
| Condition | Breast cancer surgery |
| Intervention | Intervention: A physiotherapy-led exercise programme incorporating behavioural strategies. The intervention package will involve different phases to encourage early restricted movement, progression of exercises to incorporate range of motion and strengthening, followed by a maintenance phase to ensure that flexibility and strength are maintained over time. Control group: Best practice usual care. |
| Intervention type | Behavioural |
| Primary outcome measure | Arm, shoulder and hand function measured using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months (0=no functional problems, 100=maximal problems) |
| Secondary outcome measures | 1. Assessment of arm, shoulder and hand function (DASH) subscales measured at baseline, 6 and 12 months 2. Health-related QoL as measured by SF-12 & EQ-5D-5L, measured at baseline, 6 and 12 months 3. Acute and chronic postoperative pain measured using pain items from DASH and Doleur Neuropathique (DN4) to capture neuropathic pain, measured at baseline, 6 weeks, 6 and 12 months 4. Surgical site infection measured at 6 weeks (clinical criteria) 5. Postoperative symptoms including indicators of lymphoedema at 6 and 12 months (DASH and lymphoedema screening items [Armer et al., 2003]) 6. Healthcare resource use measured at 6 and 12 months (self-report) |
| Overall study start date | 01/03/2015 |
| Overall study end date | 14/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 350 |
| Total final enrolment | 392 |
| Participant inclusion criteria | Inclusion criteria as of 31/03/2016: 1. Women, age > 18 years 2. Histologically confirmed invasive or non-invasive primary breast cancer scheduled for surgical excision 3. Considered high risk of developing shoulder problems after surgery, defined by one or more of the following: 3.1. Planned axillary node clearance (ANC) 3.2. Planned radiotherapy (RT) to axilla and/or supraclavicular 3.3. Existing shoulder problems (based upon PROSPER screening criteria) 3.4. Obesity defined as BMI >30 3.5. Any subsequent axillary surgery related to primary surgery e.g. ANC conducted after sentinel lymph node biopsy 4. Willing and able to comply with the protocol 5. Written informed consent 6. Any later decision (made within 6 weeks of surgery) to refer for RT to axilla and/or supraclavicular Note: 1. Women who have had previous breast surgery (e.g. excision of benign tumour or breast cyst) are eligible for invitation 2. Women who have had previous contralateral (opposite side) mastectomy are eligible for invitation Original inclusion criteria: 1. Female ≥ 18 years, no upper age limit 2. Histologically confirmed invasive or non-invasive early breast cancer scheduled for surgical excision of breast cancer 3. Predicted high risk of developing shoulder problems post breast cancer surgery (existing shoulder problems/planned axillary surgery/radiotherapy) 4. Willing and able to comply with the protocol |
| Participant exclusion criteria | Exclusion criteria as of 31/03/2016: 1. Males 2. Women having immediate reconstructive surgery 3. Women having sentinel lymph node biopsy (SLNB) with or without breast surgery unless have other high risk criteria 4. Women having bilateral breast surgery 5. Evidence of known metastatic disease at time of recruitment Original exclusion criteria: 1. Males with breast cancer 2. Major psychiatric disorder or psychological disorder, including substance abuse that would preclude engagement with the programme 3. Detectable metastatic disease 4. Planned immediate reconstructive surgery 5. Bilateral breast surgery |
| Recruitment start date | 01/10/2015 |
| Recruitment end date | 31/07/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coventry
CV2 2DX
United Kingdom
Old Road
Oxford
Oxford
OX3 7LE
United Kingdom
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom
Moat Road
Walsall
WS2 9PS
United Kingdom
Chesterfield
S44 5BL
United Kingdom
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Haslingden Road
Blackburn
BB22 3HH
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Williams Avenue
Dorchester
Dorset
DT1 2JY
United Kingdom
Nuneaton
Warwickshire
Nuneaton
CV10 7DJ
United Kingdom
Hereford
HR1 2BN
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Milton Keynes
MK6 5LD
United Kingdom
Parkfield Road
Taunton
Somerset
TA1 5DA
United Kingdom
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Truro
TR1 3LJ
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Sponsor information
University/education
University House
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom
| Website | http://www2.warwick.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Hospital/treatment centre
University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this trial will inform clinical practice on the identification and management of women at risk of shoulder conditions after breast cancer surgery. In addition to the main HTA report, results will be published in peer-reviewed journals and presented at scientific meetings. We intend to publish the trial protocol in an open access journal (e.g., BioMed Central or BMJ Open). |
| IPD sharing plan | Not provided at registration. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/03/2018 | Yes | No | |
| Other publications | intervention development | 18/06/2018 | Yes | No | |
| Results article | qualitative results | 11/05/2021 | 13/05/2021 | Yes | No |
| Results article | 10/11/2021 | 12/11/2021 | Yes | No | |
| Plain English results | 23/11/2021 | 23/11/2021 | No | Yes | |
| Results article | 01/02/2022 | 01/03/2022 | Yes | No | |
| Plain English results | 02/03/2023 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
02/03/2023: Results in plain English uploaded to the trial outputs table.
01/03/2022: Publication reference added.
23/11/2021: The following changes have been made:
1. Results in plain English uploaded as an additional file.
2. The trial participating centres "Milton Keynes University Hospital NHS Foundation Trust", "Musgrove Park Hospital", "Queen Alexandra Hospital", "Royal Cornwall Hospitals NHS Trust" and "Royal Stoke University Hospitals" have been added
3. The trial participating centre "Burnley General Hospital " has been changed to "East Lancashire Hospitals NHS Trust".
19/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2017 to 31/07/2017.
2. The trial participating centres "Birmingham City Hospital, Sandwell & West Birmingham NHS Trust", "Dorset County Hospital", "George Elliot Hospital NHS Trust", "Hereford County Hospital Wye Valley NHS Trust" and "Macclesfield District General Hospital" have been added and the addresses of the trial participating centres "Oxford University Hospitals NHS Foundation Trust", "Royal Blackburn Hospital" and "Burnley General Hospital" have been updated.
12/11/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/05/2021: PubMed address added.
13/05/2021: Publication reference added.
07/04/2020: The intention to publish date was changed from 31/05/2020 to 30/06/2020.
19/11/2019: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2019 to 14/03/2020.
2. The intention to publish date has been changed from 01/05/2019 to 31/05/2020.
20/06/2018: Publication reference added.
27/03/2018: Publication reference added.
24/08/2016: Royal Blackburn Hospital and Burnley General Hospital added to the trial participating centres.
24/06/2016: Cancer Help UK lay summary link added.
31/03/2016: Ethics approval information added. In addition, the University of Warwick has been added as a sponsor, the inclusion and exclusion criteria have been updated and four more trial participating centres have been added.
