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Hatha Yoga for Patients With Colorectal Cancer (YoCo)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669109
First Posted: August 20, 2012
Last Update Posted: January 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Holger Cramer, Universität Duisburg-Essen:

Primary Outcome Measures:
  • Health-related quality of life [ Time Frame: Week 10 ]
    Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: Week 22 ]
    - Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)

  • Fatigue [ Time Frame: Week 10, week 22 ]
    Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

  • Anxiety, depression [ Time Frame: Week 10, week 22 ]
    Hospital Anxiety and Depression Scale (HADS)

  • Sleep quality [ Time Frame: Week 10, week 22 ]
    Pittsburgh Sleep Quality Index (PSQI)

  • Safety [ Time Frame: Week 0-22 ]
    Number and severity of adverse events

  • Spiritual well-being [ Time Frame: Week 10, week 22 ]
    - Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)


Other Outcome Measures:
  • Body awareness/bodily dissociation [ Time Frame: Week 10, week 22 ]
    • Scale of Body Connection (SBC)
    • Used in mediation analysis

  • Body efficacy expectation [ Time Frame: Week 10, week 22 ]
    • Body Efficacy-Expectation Scale
    • Used in mediation analysis

  • Qualitative Interviews [ Time Frame: Week 11 ]

Enrollment: 54
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669109


Locations
Germany
Department of Internal and Complementary Medicine, Immanuel Hospital Berlin
Berlin, Germany, 14109
Department for Internal and Integrative Medicine, Essen-Mitte Clinics
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holger Cramer, Postdoctoral fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01669109     History of Changes
Other Study ID Numbers: 12-4957-BO
First Submitted: August 16, 2012
First Posted: August 20, 2012
Last Update Posted: January 10, 2014
Last Verified: January 2014

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

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