Yoga Intervention for Reducing Fatigue in Cancer Patients

Cancer Clinical Trial

— Carfi  

Official title:

Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433793
• Other study ID #: DRKS00016034
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 1, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Behavioral:
• Yoga 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).

Locations

Country	Name	City	State
Germany	Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine	Würzburg	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	German Cancer Aid

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from self-reported fatigue after participation in yoga therapy.	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	T0: At the beginning of the study, T1: after 9 weeks
Secondary	Changes from Quality of life in cancer patients	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	T0: At the beginning of the study, T1: after 9 weeks
Secondary	Changes from Depression	self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression	T0: At the beginning of the study, T1: after 9 weeks