Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: relaxation training
* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: relaxation training<br>Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery. | Behavioral: relaxation training<br>* 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.<br>|
| Experimental: acupuncture<br>Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery. | Other: acupuncture<br>* 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.<br>|
| Experimental: relaxation training and acupuncture<br>Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery. | Behavioral: relaxation training<br>* 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.<br>Other: acupuncture<br>* 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.<br>|
| No Intervention: usual care<br>Patients receive usual senological treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presurgical psychological distress | Measured by 100mm visual analog scale 1 day pre surgery | expected average of 13 days | 
| postsurgical pain | Measured by 100mm visual analog scale 1 day post surgery | expected average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postsurgical psychological distress | Measured by 100mm visual analog scale 1 day post surgery | expected average of 15 days | 
| postsurgical psychological distress | Measured by 100mm visual analog scale 1 week post surgery | expected average of 21 days | 
| postsurgical pain | Measured by 100mm visual analog scale 1 week post surgery | expected average of 21 days | 
| postsurgical nausea | Measured by 100mm visual analog scale 1 day post surgery | expected average of 15 days | 
| postsurgical nausea | Measured by 100mm visual analog scale 1 week post surgery | expected average of 21 days | 
| postsurgical fatigue | Measured by 100mm visual analog scale 1 day post surgery | expected average of 15 days | 
| postsurgical fatigue | Measured by 100mm visual analog scale 1 week post surgery | expected average of 21 days | 
| intraoperative analgesia use | intraoperative analgesia use is taken from operative logs | expected average of 14 days | 
| intraoperative anesthesia use | intraoperative anesthesia use is taken from operative logs | expected average of 14 days | 
| postoperative analgesia use | postoperative analgesia use is taken from medical records | expected average of 15 days | 
| immunemodulation | natural killer cell activity is measured at begin of surgery | expected average of 14 days | 
| immunemodulation | natural killer cell activity is measured at end of surgery | expected average of 14 days | 
| Number of patients with adverse events | Number of patients with adverse events are measured one week post surgery | expected average of 21 days | 
| presurgical psychological distress | Measured by Profile of Mood States (POMS) 1 day pre surgery | expected average of 13 days | 
| postsurgical psychological distress | Measured by Profile of Mood States (POMS) 1 day post surgery | expected average of 15 days | 
| postsurgical psychological distress | Measured by Profile of Mood States (POMS) 1 week post surgery | expected average of 21 days |