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Hatha Yoga for Patients With Colorectal Cancer (YoCo)

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ClinicalTrials.gov Identifier: NCT01669109
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Hatha yoga Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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


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

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

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

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

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

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


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

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

  3. Qualitative Interviews [ Time Frame: Week 11 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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 Posted: August 20, 2012    Key Record Dates
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