NCT01669109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

August 16, 2012

Last Update Submit

January 9, 2014

Conditions

Keywords

YogaColorectal NeoplasmsQuality of LifeRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life

    Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)

    Week 10

Secondary Outcomes (6)

  • Health-related quality of life

    Week 22

  • Fatigue

    Week 10, week 22

  • Anxiety, depression

    Week 10, week 22

  • Sleep quality

    Week 10, week 22

  • Safety

    Week 0-22

  • +1 more secondary outcomes

Other Outcomes (3)

  • Body awareness/bodily dissociation

    Week 10, week 22

  • Body efficacy expectation

    Week 10, week 22

  • Qualitative Interviews

    Week 11

Study Arms (2)

Hatha yoga

EXPERIMENTAL

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

Behavioral: Hatha yoga

Usual care

NO INTERVENTION

Patients continue their self-directed usual care

Interventions

Hatha yogaBEHAVIORAL
Hatha yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • UICC stage IV
  • further active oncological diseases
  • diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder
  • pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Internal and Complementary Medicine, Immanuel Hospital Berlin

Berlin, 14109, Germany

Location

Department for Internal and Integrative Medicine, Essen-Mitte Clinics

Essen, 45276, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral fellow

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 20, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations