Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Auswirkungen von Yoga auf die Lebensqualität von Brustkrebspatientinnen

23. September 2026 aktualisiert von: Andreas Michalsen, Charite University, Berlin, Germany

Effects of Two Different Online Yoga Interventions on the Quality of Life of Breast Cancer Patients Compared With Waiting List - a Three-arm Randomized Controlled Trial

This study investigates the effects of two different online yoga interventions on the health-related quality of life in breast cancer patients. Qualitative and quantitative data will be collected.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:

  • Intervention group 1 will receive an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study mainly includes physical and relaxation exercises.
  • Intervention group 2 will receive a meditative yoga intervention online including physical and meditation exercises and also ideologically neutral explanations of the ethical aspects of yoga.
  • Group 3 consists of a waiting list control group, combined with the offer to participate in a yoga intervention after 6 months.

Studientyp

Interventionell

Einschreibung (Geschätzt)

138

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
    • State of Berlin
      • Berlin, State of Berlin, Deutschland, 14109
        • Rekrutierung
        • Charite University
        • Kontakt:
        • Hauptermittler:
          • Andreas Michalsen, Prof.Dr.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • Histologically confirmed diagnosis of non-metastatic breast cancer (TNM stage I-III) up to 5 years after diagnosis
  • Primary therapy completed for at least 3 months
  • Limitation of the quality of life due to the cancer (indication of at least 4 out of 10 points on the numerical analogue scale)
  • Willingness to participate in the study and signed informed consent.

Exclusion Criteria:

  • Current or planned chemotherapy, radiation or surgery
  • Severe physical or psychopharmacologically treated psychiatric comorbidity due to which a patient is unable to participate in the study
  • Pregnancy/breastfeeding
  • Participation in other clinical trials with behavioral, psychological, or complementary medicine interventions
  • Immobility or limitation for gymnastic exercise due to orthopedic, neurologic, or other medical cause
  • regular meditation practice >2x/month
  • regular yoga practice >2x/month

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Iyengar yoga

Intervention group 1 receives an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study primarily includes physical and relaxation exercises.
Verhalten: Iyengar Yoga

Iyengar Yoga focuses on the correct alignment of the body while practicing the physical exercises of yoga. Props are used to support the body in finding the right alignment. Relaxation is also part of this intervention. Participiants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes.
Experimental: Meditative yoga

Intervention group 2 receives an Integrative yoga intervention online including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga.
Verhalten: Meditative Yoga

Meditative Yoga in the context of this study means practicing the physical exercises of yoga as well as meditation. Additionally, each week one of the yamas/niyamas, which are ethical principles to live by in the Yoga philosophy, will be presented at the beginning of each class and will form the theme of the class. Participants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes.
Kein Eingriff: Waitlist Control Group

Group 3 consists of a waitlist control group. Participants will be offered the opportunity to attend a yoga intervention after 4 months. The patients in this waiting list control group are allowed to choose the yoga course after 6 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Zeitfenster: Date of inclusion (baseline), after 8 weeks

Assessing full scale, range 0-40, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-40, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-52, higher score meaning a better outcom
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Perceived Stress Scale (PSS-10)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-40, lower score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Flourishing Scale (FS-D)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 8-56, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Self-Compassion Scale (SCS-D)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Mean score of 12 items, range 1-5, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Self-Efficacy Scale (ASKU)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Mean score of 3 items, range 1-5, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Sociodemographic measures
Zeitfenster: Date of inclusion (baseline)

Age, education level, personal income, household income, employment status, job description, marital status, household members, days of sick leave past 3 months
Date of inclusion (baseline)
Behavioral questions: cigarettes
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Number of cigarettes on average per day in the last month
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioral questions: alcohol
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Number of alcoholic beverages on average per week in the last month
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Expectation question
Zeitfenster: Date of inclusion (baseline)

expectation of effectiveness of the intervention on a 5-point likert scale, how they expect to handle the intervention on a 5-point likert scale, higher score meaning better outcome
Date of inclusion (baseline)
Behavioural question
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

diet
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioural question 2
Zeitfenster: Date of inclusion (baseline)

Practice of other mindfulness practices besides Yoga
Date of inclusion (baseline)
Behavioural question 3
Zeitfenster: Date of inclusion (baseline)

Yoga styles were practiced before
Date of inclusion (baseline)
Behavioural question 4
Zeitfenster: Date of inclusion (baseline)

If and how often yoga is practiced regularly
Date of inclusion (baseline)
Functional Assessment of Cancer Therapy - General (FACT-G)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-108, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Yama/Niyama Questionnaire - YaNiQ
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-100, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Assessing full scale, range 0-42, lower score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Qualitative interviews
Zeitfenster: 8 weeks after inclusion

Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.
8 weeks after inclusion
Heart Rate Variability (HRV)
Zeitfenster: Date of inclusion (baseline), after 8 weeks

24h measuring by Faros 180
Date of inclusion (baseline), after 8 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Charite University, Berlin, Germany

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Mai 2022

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

7. April 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. April 2022

Zuerst gepostet (Tatsächlich)

14. April 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YOMA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren