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OpenTrials
Completed

NCT Number: NCT01669109

Hatha Yoga for Patients With Colorectal Cancer

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Complementary Medicine, Immanuel Hospital Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hatha yoga

Behavioral

Primary outcomes

  1. Health-related quality of life

    Time frame: Week 10

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

Secondary outcomes

  1. Health-related quality of life

    Time frame: Week 22

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

  2. Fatigue

    Time frame: Week 10, week 22

    Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

  3. Anxiety, depression

    Time frame: Week 10, week 22

    Hospital Anxiety and Depression Scale (HADS)

  4. Sleep quality

    Time frame: Week 10, week 22

    Pittsburgh Sleep Quality Index (PSQI)

  5. Safety

    Time frame: Week 0-22

    Number and severity of adverse events

  6. Spiritual well-being

    Time frame: Week 10, week 22

    • Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)

Other outcomes

  1. Body awareness/bodily dissociation

    Time frame: Week 10, week 22

    • Scale of Body Connection (SBC)
    • Used in mediation analysis

  2. Body efficacy expectation

    Time frame: Week 10, week 22

    • Body Efficacy-Expectation Scale
    • Used in mediation analysis

  3. Qualitative Interviews

    Time frame: Week 11

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: YoCo

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2012
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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