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

niversity of Warwick0 个研究点目标入组 392 人开始时间: 2015年2月4日最近更新: 2023年3月13日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29574439 protocol 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29914494 intervention development 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33980512/ qualitative results (added 13/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34759002/ (added 12/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35220995/ (added 01/03/2022)

•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
•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

•Exclusion criteria as of 31/03/2016:
•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

发起方

niversity of Warwick