Joogan vaikutukset rintasyöpäpotilaiden elämänlaatuun
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
State of Berlin
-
Berlin, State of Berlin, Saksa, 14109
- Rekrytointi
- Charite University
-
Ottaa yhteyttä:
- Miriam Roesner
- Puhelinnumero: 030 80505 682
- Sähköposti: m.roesner@immanuel.de
-
Päätutkija:
- Andreas Michalsen, Prof.Dr.
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
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. |
|
Kokeellinen: 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. |
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. |
|
Ei väliintuloa: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Date of inclusion (baseline)
|
Practice of other mindfulness practices besides Yoga |
Date of inclusion (baseline)
|
|
Behavioural question 3
Aikaikkuna: Date of inclusion (baseline)
|
Yoga styles were practiced before |
Date of inclusion (baseline)
|
|
Behavioural question 4
Aikaikkuna: Date of inclusion (baseline)
|
If and how often yoga is practiced regularly |
Date of inclusion (baseline)
|
|
Functional Assessment of Cancer Therapy - General (FACT-G)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Qualitative interviews
Aikaikkuna: 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)
Aikaikkuna: Date of inclusion (baseline), after 8 weeks
|
24h measuring by Faros 180 |
Date of inclusion (baseline), after 8 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- YOMA
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .