Cancer, Fatigue
Conditions
Keywords
Yoga, Mindfulness based Intervention, Fatigue, Cancer Patients
Brief summary
Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8 week yoga therapy (one hour a week) in patients with different cancer types on self-reported fatigue will be tested.
Detailed description
Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting treatments are increasingly used to alleviate the burden of fatigue. This study examines the short-term effects of yoga on fatigue, depression and quality of life. The aim of this study will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life
Interventions
BEHAVIORALYoga therapy
One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the nakrasana) 4) Pelvis opening (adapted variation of the supta baddha konasana) 5) Shoulder bridge (setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana).
Sponsors
German Cancer Aid
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Intervention model description
A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* oncological disease * planned to undergo cancer related treatment at radiotherapy outpatient clinic or the interdisciplinary oncological therapy outpatient clinic * reported fatigue symptoms: (intensity ≥4, impairment ≥ 5).
Exclusion criteria
* insufficient knowledge of German * severe emotional or physical impairment * more than 50km distance to the university hospital which would require travelling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from self-reported fatigue after participation in yoga therapy. | T0: At the beginning of the study, T1: after 9 weeks | Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Quality of life in cancer patients | T0: At the beginning of the study, T1: after 9 weeks | self-reported Quality of life in cancer patients, measured with European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire -Cancer 15 Palliativ (EORTC-QLQ-C15-Pal); Item 1- 14: Scale 1-4; Higher scores represent lower quality of life, Item 15: Scale 1-7; a higher value represents higher Overall Quality of life |
| Changes from Depression | T0: At the beginning of the study, T1: after 9 weeks | self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression |
Countries
Germany
Outcome results
None listed