Yoga Intervention for Reducing Fatigue in Cancer Patients

Not Applicable

Completed

• Conditions: Fatigue; Cancer
• Interventions: Behavioral: Yoga therapy

• Registration Number: NCT04433793
• Lead Sponsor: Wuerzburg University Hospital

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

Study Timeline

• Study Start: 2018-10-12
• Primary Completion: 2020-03-16
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2020-10
• Study Completion: 2020-10-01
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga group	Yoga therapy	Patients in the yoga group will receive yoga therapy, one hour every week for eight weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine; 🇩🇪 Würzburg, Bayern, Germany