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Effetti dello yoga sulla qualità della vita dei pazienti con cancro al seno

23 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

138

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
    • State of Berlin
      • Berlin, State of Berlin, Germania, 14109
        • Reclutamento
        • Charite University
        • Contatto:
        • Investigatore principale:
          • Andreas Michalsen, Prof.Dr.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Date of inclusion (baseline)

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

Yoga styles were practiced before
Date of inclusion (baseline)
Behavioural question 4
Lasso di tempo: Date of inclusion (baseline)

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Qualitative interviews
Lasso di tempo: 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)
Lasso di tempo: Date of inclusion (baseline), after 8 weeks

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Charite University, Berlin, Germany

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 maggio 2022

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

7 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

7 aprile 2022

Primo Inserito (Effettivo)

14 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • YOMA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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