Colorectal Neoplasms
Conditions
Keywords
Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial
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.
Interventions
BEHAVIORALHatha yoga
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | Week 10 | Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety, depression | Week 10, week 22 | Hospital Anxiety and Depression Scale (HADS) |
| Sleep quality | Week 10, week 22 | Pittsburgh Sleep Quality Index (PSQI) |
| Safety | Week 0-22 | Number and severity of adverse events |
| Spiritual well-being | Week 10, week 22 | \- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) |
| Health-related quality of life | Week 22 | \- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) |
| Fatigue | Week 10, week 22 | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body efficacy expectation | Week 10, week 22 | * Body Efficacy-Expectation Scale * Used in mediation analysis |
| Qualitative Interviews | Week 11 | — |
| Body awareness/bodily dissociation | Week 10, week 22 | * Scale of Body Connection (SBC) * Used in mediation analysis |
Countries
Germany
Outcome results
None listed