Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hatha Yoga for Patients With Colorectal Cancer (YoCo)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01669109
First received: August 16, 2012
Last updated: January 9, 2014
Last verified: January 2014
  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:


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

  • Qualitative Interviews [ Time Frame: Week 11 ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: January 9, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 24, 2014