Breast cancer surgery Cancer
Conditions
Interventions
Intervention:
A physiotherapy-led exercise programme incorporating behavioural strategies. The intervention package will involve different phases to encourage early restricted movement
Sponsors
University of Warwick
University Hospitals Coventry & Warwickshire NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Contacts
Public ContactLauren Betteley
Outcome results
None listed