Clinical trial NCT04433793: Yoga Intervention for Reducing Fatigue in Cancer Patients
Official title: Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Cancer
Keywords: Yoga
Mindfulness based Intervention
Fatigue
Cancer Patients
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2020-06-16
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from self-reported fatigue after participation in yoga therapy.
timeFrame: T0: At the beginning of the study, T1: after 9 weeks
Secondary outcomes:
measure: Changes from Quality of life in cancer patients
timeFrame: T0: At the beginning of the study, T1: after 9 weeks
measure: Changes from Depression
timeFrame: T0: At the beginning of the study, T1: after 9 weeks
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine
state: Bayern
Study officials:
References:
citation: 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.