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

13 juni 2019 uppdaterad av: Silke Lange, Universität Duisburg-Essen

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Tyskland
      • Essen, Tyskland, 45136
        • Department of Senology, Kliniken Essen-Mitte

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: relaxation training
Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.
Beteende: relaxation 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.
Experimentell: acupuncture
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.
Övrig: acupuncture
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.
Experimentell: relaxation training and acupuncture
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.
Beteende: relaxation 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.
Övrig: acupuncture
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.
Inget ingripande: usual care
Patients receive usual senological treatment

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
presurgical psychological distress
Tidsram: expected average of 13 days
Measured by 100mm visual analog scale 1 day pre surgery
expected average of 13 days
postsurgical pain
Tidsram: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
expected average of 15 days

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universität Duisburg-Essen

Utredare

  • Studiestol: Gustav J. Dobos, Prof, Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2014

Primärt slutförande (Faktisk)

1 november 2018

Avslutad studie (Faktisk)

1 november 2018

Studieregistreringsdatum

Först inskickad

21 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

27 oktober 2014

Första postat (Uppskatta)

28 oktober 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2019

Senast verifierad

1 juni 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 14-5778-BO

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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