Breast Neoplasms
Conditions
Brief summary
Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.
Interventions
BEHAVIORALrelaxation training
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: Body Scan, mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.
OTHERacupuncture
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* clinically proven breast cancer with an indication for breast conserving surgery with max. 50% volume reduction * physical and psychological ability to take part in relaxation training
Exclusion criteria
* serious psychiatric disorder * to time span to surgery shorter than 2 weeks or longer than 20 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presurgical psychological distress | expected average of 13 days | Measured by 100mm visual analog scale 1 day pre surgery |
| postsurgical pain | expected average of 15 days | Measured by 100mm visual analog scale 1 day post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative anesthesia use | expected average of 14 days | intraoperative anesthesia use is taken from operative logs |
| postoperative analgesia use | expected average of 15 days | postoperative analgesia use is taken from medical records |
| postsurgical psychological distress | expected average of 15 days | Measured by 100mm visual analog scale 1 day post surgery |
| postsurgical pain | expected average of 21 days | Measured by 100mm visual analog scale 1 week post surgery |
| intraoperative analgesia use | expected average of 14 days | intraoperative analgesia use is taken from operative logs |
| postsurgical fatigue | expected average of 15 days | Measured by 100mm visual analog scale 1 day post surgery |
| Number of patients with adverse events | expected average of 21 days | Number of patients with adverse events are measured one week post surgery |
| presurgical psychological distress | expected average of 13 days | Measured by Profile of Mood States (POMS) 1 day pre surgery |
| postsurgical nausea | expected average of 15 days | Measured by 100mm visual analog scale 1 day post surgery |
| immunemodulation | expected average of 14 days | natural killer cell activity is measured at begin of surgery |
Countries
Germany
Outcome results
None listed