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Hatha Yoga for Patients With Colorectal Cancer (YoCo)

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hatha yoga
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hatha yoga

Usual care

Arm Description

10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention 1 weekly class (90 minutes)

Patients continue their self-directed usual care

Outcomes

Primary Outcome Measures

Health-related quality of life
Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)

Secondary Outcome Measures

Health-related quality of life
- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Anxiety, depression
Hospital Anxiety and Depression Scale (HADS)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Safety
Number and severity of adverse events
Spiritual well-being
- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)

Full Information

First Posted
August 16, 2012
Last Updated
January 9, 2014
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01669109
Brief Title
Hatha Yoga for Patients With Colorectal Cancer
Acronym
YoCo
Official Title
Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hatha yoga
Arm Type
Experimental
Arm Description
10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention 1 weekly class (90 minutes)
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients continue their self-directed usual care
Intervention Type
Behavioral
Intervention Name(s)
Hatha yoga
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Time Frame
Week 22
Title
Fatigue
Description
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time Frame
Week 10, week 22
Title
Anxiety, depression
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Week 10, week 22
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Week 10, week 22
Title
Safety
Description
Number and severity of adverse events
Time Frame
Week 0-22
Title
Spiritual well-being
Description
- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)
Time Frame
Week 10, week 22
Other Pre-specified Outcome Measures:
Title
Body awareness/bodily dissociation
Description
Scale of Body Connection (SBC) Used in mediation analysis
Time Frame
Week 10, week 22
Title
Body efficacy expectation
Description
Body Efficacy-Expectation Scale Used in mediation analysis
Time Frame
Week 10, week 22
Title
Qualitative Interviews
Time Frame
Week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Internal and Complementary Medicine, Immanuel Hospital Berlin
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
Department for Internal and Integrative Medicine, Essen-Mitte Clinics
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26228466
Citation
Cramer H, Pokhrel B, Fester C, Meier B, Gass F, Lauche R, Eggleston B, Walz M, Michalsen A, Kunz R, Dobos G, Langhorst J. A randomized controlled bicenter trial of yoga for patients with colorectal cancer. Psychooncology. 2016 Apr;25(4):412-20. doi: 10.1002/pon.3927. Epub 2015 Jul 29.
Results Reference
derived

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Hatha Yoga for Patients With Colorectal Cancer

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