Breast cancer
Conditions
Interventions
1. Cognitive behavioral therapy (e-CBT) or 2. Educational intervention consisting of information about surgery and a healthy lifestyle (EDU). 3. The third, non-randomized group receives treatment as u
Sponsors
KWF Kankerbestrijding and ESA (European Society of Anaesthesiology)
Eligibility
Inclusion criteria
Inclusion criteria: for both groups - Women undergoing surgery for breast cancer - Age = 18 years old Inclusion criteria for the randomized group - Women scoring = 8 on the HADSa, = 3 on the Surgical fear item, = 5 on the CARS, or = 18 on the PCS, will be included in the RCT. Inclusion criteria for the non-randomized group - Women scoring < 8 on the HADSa, < 3 on the Surgical fear item, < 5 on the CARS, or < 18 on the PCS will be included as a control group, receiving treatment as usual.
Exclusion criteria
Exclusion criteria: for both groups - Preventive breast surgery - Bilateral surgery - Not able to understand Dutch - No internet access - Visual or hearing impairments interfering with reading and listening to the online material - Known or suspected severe psychiatric disorder - Current litigation procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent pain after breast cancer treatment (PPBCT), six months after breast cancer surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain intensity scores (intercept and slope) during the first postoperative week (Pain Diary) - Cessation of postoperative opioid use (no. of days) - Mean pain intensity in the operated area at 2, 6 and 12 months (NRS) - Neuropathic pain (DN4) - Pain interference at 2, 6 and 12 months as measured with the BPI - Quality of life before surgery and at 6 and 12 months (EORTC-QLQ – BC) - Unspecific symptoms, before surgery and at 6 and 12 months (hot flushes (EORTC-QLQ – BC23), concentration problems, sleeping problems (added to BC23) - Depression, before surgery and at 2, 6 and 12 months (PROMIS short form 4A ) - Pain sensitivity preoperatively and at 1 week and 6 months and post-surgery assessed with quan-titative sensory testing (QST) and a conditioned pain modulation algorithm (CPM) - Shoulder function operated side, before surgery and at 6 and 12 months (DASH) Potential mediators - General anxiety (HADS-A) - Pain catastrophizing (PCS) - Fear of cancer recurrence (CARS) before surgery and at 2, 6 and 12 months Procedure related parameter - Compliance with intervention Baseline and surgery parameters | — |
Contacts
Public ContactH.M.S. Theunissen
Maastricht UMC+
Outcome results
None listed