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Effekter av yoga på livskvaliteten til brystkreftpasienter

23. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

138

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 14109
        • Rekruttering
        • Charite University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andreas Michalsen, Prof.Dr.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Date of inclusion (baseline)

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

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

If and how often yoga is practiced regularly
Date of inclusion (baseline)
Functional Assessment of Cancer Therapy - General (FACT-G)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative interviews
Tidsramme: 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)
Tidsramme: Date of inclusion (baseline), after 8 weeks

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. mai 2022

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

7. april 2022

Først innsendt som oppfylte QC-kriteriene

7. april 2022

Først lagt ut (Faktiske)

14. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YOMA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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