Hatha Yoga for Patients With Colorectal Cancer (YoCo)

January 9, 2014 updated by: Holger Cramer, Universität Duisburg-Essen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Department of Internal and Complementary Medicine, Immanuel Hospital Berlin
      • Essen, Germany, 45276
        • Department for Internal and Integrative Medicine, Essen-Mitte Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Week 10
Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Week 22
- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Week 22
Fatigue
Time Frame: Week 10, week 22
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Week 10, week 22
Anxiety, depression
Time Frame: Week 10, week 22
Hospital Anxiety and Depression Scale (HADS)
Week 10, week 22
Sleep quality
Time Frame: Week 10, week 22
Pittsburgh Sleep Quality Index (PSQI)
Week 10, week 22
Safety
Time Frame: Week 0-22
Number and severity of adverse events
Week 0-22
Spiritual well-being
Time Frame: Week 10, week 22
- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)
Week 10, week 22

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body awareness/bodily dissociation
Time Frame: Week 10, week 22
  • Scale of Body Connection (SBC)
  • Used in mediation analysis
Week 10, week 22
Body efficacy expectation
Time Frame: Week 10, week 22
  • Body Efficacy-Expectation Scale
  • Used in mediation analysis
Week 10, week 22
Qualitative Interviews
Time Frame: Week 11
Week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-4957-BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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