Samstag, 4. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE

Effects of Yoga on the Quality of Life of Breast Cancer Patients

Rekrutierend

NCT-Nummer:
NCT05327543

Studienbeginn:
Mai 2022

Letztes Update:
28.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

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

treatment arms:

- Intervention group 1 will receive an Iyengar yoga intervention 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 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 4 months.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) (Time Frame - Date of inclusion (baseline), after 8 weeks):
Assessing full scale, range 0-40, higher score meaning a better outcome



Secondary outcome:

1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-40, higher score meaning a better outcome

2. Functional Assessment of Cancer Therapy: Fatigue (FACIT-F) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-52, higher score meaning a better outcom

3. Perceived Stress Scale (PSS-10) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-40, lower score meaning a better outcome

4. Flourishing Scale (FS-D) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 8-56, higher score meaning a better outcome

5. Self-Compassion Scale (SCS-D) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Mean score of 12 items, range 1-5, higher score meaning a better outcome

6. Self-Efficacy Scale (ASKU) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Mean score of 3 items, range 1-5, higher score meaning a better outcome

7. Sociodemographic measures (Time Frame - 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

8. Behavioral questions: cigarettes (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Number of cigarettes on average per day in the last month

9. Behavioral questions: alcohol (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Number of alcoholic beverages on average per week in the last month

10. Expectation question (Time Frame - 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

11. Behavioural question (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
diet

12. Behavioural question 2 (Time Frame - Date of inclusion (baseline)):
Practice of other mindfulness practices besides Yoga

13. Behavioural question 3 (Time Frame - Date of inclusion (baseline)):
Yoga styles were practiced before

14. Behavioural question 4 (Time Frame - Date of inclusion (baseline)):
If and how often yoga is practiced regularly

15. Functional Assessment of Cancer Therapy - General (FACT-G) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-108, higher score meaning a better outcome

16. Yama/Niyama Questionnaire - YaNiQ (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-100, higher score meaning a better outcome

17. Hospital Anxiety and Depression Scale (HADS) (Time Frame - Date of inclusion (baseline), after 8 weeks, after 16 weeks):
Assessing full scale, range 0-42, lower score meaning a better outcome

Studien-Arme

  • Experimental: Iyengar yoga
    Intervention group 1 receives an Iyengar yoga intervention 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.
  • Experimental: Meditative yoga
    Intervention group 2 receives an Integrative yoga intervention including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga.
  • No Intervention: 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 4 months.

Geprüfte Regime

  • 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.
  • 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.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Effects of Yoga on the Quality of Life of Breast Cancer Patients"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.