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Hatha Yoga for Patients With Colorectal Cancer (YoCo)

This study is currently recruiting participants.
Verified February 2013 by Universität Duisburg-Essen
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01669109
First received: August 16, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
 Behavioral: Hatha yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Health-related quality of life [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
    - Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)

  • Fatigue [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

  • Anxiety, depression [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)

  • Sleep quality [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index (PSQI)

  • Safety [ Time Frame: Week 0-22 ] [ Designated as safety issue: Yes ]
    Number and severity of adverse events

  • Spiritual well-being [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    - Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)


Other Outcome Measures:
  • Body awareness/bodily dissociation [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    • Scale of Body Connection (SBC)
    • Used in mediation analysis

  • Body efficacy expectation [ Time Frame: Week 10, week 22 ] [ Designated as safety issue: No ]
    • Body Efficacy-Expectation Scale
    • Used in mediation analysis


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hatha yoga
  • 10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention
  • 1 weekly class (90 minutes)
 Behavioral: Hatha yoga
No Intervention: Usual care
Patients continue their self-directed usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669109

Contacts
Contact: Holger Cramer, PhD +49 201 174 25054 h.cramer@kliniken-essen-mitte.de

Locations
Germany
Department of Internal and Complementary Medicine, Immanuel Hospital Berlin Recruiting
Berlin, Germany, 14109
Contact: Andreas Michalsen, MD         A.Michalsen@immanuel.de    
Principal Investigator: Andreas Michalsen, MD            
Department for Internal and Integrative Medicine, Essen-Mitte Clinics Active, not recruiting
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
  More Information

No publications provided

Responsible Party: Holger Cramer, Postdoctoral fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01669109     History of Changes
Other Study ID Numbers: 12-4957-BO
Study First Received: August 16, 2012
Last Updated: February 4, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universität Duisburg-Essen:
Yoga
Colorectal Neoplasms
Quality of Life
Randomized Controlled Trial

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013