Hatha Yoga for Patients With Colorectal Cancer

Colorectal Neoplasms Clinical Trial

— YoCo  

Official title:

Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669109
• Other study ID #: 12-4957-BO
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: January 9, 2014
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colorectal cancer

• UICC stage I-III

• between 2 and 48 months post-surgery

• age at least 18 years

• physical and cognitive ability to follow the yoga intervention

Exclusion Criteria:

• UICC stage IV

• further active oncological diseases

• diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder

• pregnancy or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• Hatha yoga

Locations

Country	Name	City	State
Germany	Department of Internal and Complementary Medicine, Immanuel Hospital Berlin	Berlin
Germany	Department for Internal and Integrative Medicine, Essen-Mitte Clinics	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body awareness/bodily dissociation	Scale of Body Connection (SBC); Used in mediation analysis	Week 10, week 22	No
Other	Body efficacy expectation	Body Efficacy-Expectation Scale; Used in mediation analysis	Week 10, week 22	No
Other	Qualitative Interviews		Week 11	No
Primary	Health-related quality of life	Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)	Week 10	No
Secondary	Health-related quality of life	- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)	Week 22	No
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Week 10, week 22	No
Secondary	Anxiety, depression	Hospital Anxiety and Depression Scale (HADS)	Week 10, week 22	No
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Week 10, week 22	No
Secondary	Safety	Number and severity of adverse events	Week 0-22	Yes
Secondary	Spiritual well-being	- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)	Week 10, week 22	No