Clinical trial NCT05327543: Effects of Online Yoga on the Quality of Life of Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Cancer
Keywords: Yoga
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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 4 months.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Date of inclusion (baseline), after 8 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Flourishing Scale (FS-D)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Self-Compassion Scale (SCS-D)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Self-Efficacy Scale (ASKU)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Sociodemographic measures
timeFrame: Date of inclusion (baseline)
measure: Behavioral questions: cigarettes
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Behavioral questions: alcohol
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Expectation question
timeFrame: Date of inclusion (baseline)
measure: Behavioural question
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Behavioural question 2
timeFrame: Date of inclusion (baseline)
measure: Behavioural question 3
timeFrame: Date of inclusion (baseline)
measure: Behavioural question 4
timeFrame: Date of inclusion (baseline)
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Yama/Niyama Questionnaire - YaNiQ
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Other outcomes:
measure: Qualitative interviews
timeFrame: 8 weeks after inclusion
measure: Heart Rate Variability (HRV)
timeFrame: Date of inclusion (baseline), after 8 weeks
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References: