Colorectal NeoplasmsYoCoNCT01669109
Hatha Yoga for Patients With Colorectal Cancer
A study testing Hatha yoga in people with Colorectal Neoplasms, run by Universität Duisburg-Essen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Hatha yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- UICC stage IV
- further active oncological diseases
- diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder
- pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Internal and Complementary Medicine, Immanuel Hospital Berlin
Berlin, 14109
Department for Internal and Integrative Medicine, Essen-Mitte Clinics
Essen, 45276
About this study
Official title: 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Hatha yoga
- Keywords
- Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha yogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Hatha yoga | Experimental | * 10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention
* 1 weekly class (90 minutes) Receives: Behavioral: Hatha yoga |
| Usual care | No intervention | Patients continue their self-directed usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Measured: Week 10
Secondary outcomes (6)
Health-related quality of life
- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
Measured: Week 22
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Measured: Week 10, week 22
Anxiety, depression
Hospital Anxiety and Depression Scale (HADS)
Measured: Week 10, week 22
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Week 10, week 22
Safety
Number and severity of adverse events
Measured: Week 0-22
Spiritual well-being
- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)
Measured: Week 10, week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669109
- Sponsor's protocol ID
- 12-4957-BO
- Acronym
- YoCo
- Status last verified
- Jan 2014
- First submitted
- 16 Aug 2012
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26228466
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01669109
- Acronym / sponsor ID
- YoCo / 12-4957-BO
- Conditions
- Colorectal Neoplasms
- Keywords
- Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hatha yoga | Experimental | Behavioral: Hatha yoga* 10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention * 1 weekly class (90 minutes) |
| Usual care | No intervention | –Patients continue their self-directed usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- UICC stage IV
- further active oncological diseases
- diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha yoga | Behavioural | Hatha yoga |
Primary outcome
Health-related quality of life
Time frame: Week 10
Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
6 secondary outcomes
Health-related quality of life
Time frame: Week 22
Fatigue
Time frame: Week 10, week 22
Anxiety, depression
Time frame: Week 10, week 22
Sleep quality
Time frame: Week 10, week 22
Safety
Time frame: Week 0-22
Spiritual well-being
Time frame: Week 10, week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 26228466Cramer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga in people with Colorectal Neoplasms, run by Universität Duisburg-Essen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.