Phase 2
N=23
Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01324102 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. — 8.90; 12.26; 19.80; 16.80 units on a scale — p=.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Yoga therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. |
8.90; 12.26; 19.80; 16.80; 12.41; 13.00 | .004 sig |
Summary
With advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The mental and physical health consequences of cancer and its treatment may affect a Veteran's functioning and re-integration back into family, work, and daily life. Recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in Veterans. This study has three components: (1) Determine factors that increase participation in Yoga by Veterans using individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.
Eligibility Criteria
Inclusion Criteria
- Cancer treated in the past 3 years
Exclusion Criteria
- Dementia
- Psychotic Disorder
- In hospice care
Data sourced from ClinicalTrials.gov (NCT01324102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.