Condition category
Cancer
Date applied
23/01/2015
Date assigned
04/02/2015
Last edited
24/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mrs Lauren Betteley

ORCID ID

Contact details

Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 551722
prosper@warwick.ac.uk

Type

Scientific

Additional contact

Dr Julie Bruce

ORCID ID

http://orcid.org/0000-0002-8462-7999

Contact details

Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 151128
julie.bruce@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/84/10

Study information

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

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

West Midlands – Solihull Research Ethics Committee, 20/07/2015, ref: 15/WM/0224

Study design

Multicentre randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2015

Overall trial end date

28/02/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

350

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

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Coventry & Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

The Royal Wolverhampton NHS Trust
New Cross Hospital Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Walsall Healthcare NHS Trust
Walsall Manor Hospital Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Chesterfield Royal Hospital NHS Foundation Trust
Calow
Chesterfield
S44 5BL
United Kingdom

Trial participating centre

The Hillingdon Hospitals NHS Foundation Trust
Hillingdon Hospital Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB22 3HH
United Kingdom

Trial participating centre

Burnley General Hospital
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom

Sponsor information

Organisation

University of Warwick (lead sponsor)

Sponsor details

University of Warwick
University House
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom

Sponsor type

University/education

Website

Organisation

University Hospitals Coventry & Warwickshire NHS Foundation Trust

Sponsor details

University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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).

Intention to publish date

01/05/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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. 19/05/2016: Internal review. 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.