Exercise to prevent shoulder problems in patients undergoing breast cancer treatment
- Conditions
- Breast cancer surgeryCancer
- Registration Number
- ISRCTN35358984
- Lead Sponsor
- niversity of Warwick
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 392
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method <br> 1. Assessment of arm, shoulder and hand function (DASH) subscales measured at baseline, 6 and 12 months<br> 2. Health-related QoL as measured by SF-12 & EQ-5D-5L, measured at baseline, 6 and 12 months<br> 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<br> 4. Surgical site infection measured at 6 weeks (clinical criteria)<br> 5. Postoperative symptoms including indicators of lymphoedema at 6 and 12 months (DASH and lymphoedema screening items [Armer et al., 2003])<br> 6. Healthcare resource use measured at 6 and 12 months (self-report)<br>