Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy
OBJECTIVES:
Primary
- Examine the effectiveness of a restorative yoga (RY) intervention vs home yoga practice
in patients undergoing chemotherapy for ovarian cancer.
Secondary
- Examine the effectiveness of RY vs home yoga practice on depression, distress, and
sleep quality in these patients.
- Examine the acute (pre- and post-yoga class) effects in these patients.
- Test the feasibility of using behavioral strategies to enhance yoga intervention
adherence.
OUTLINE: Patients are randomized to 1 of 2 arms.
- Arm I (restorative yoga intervention): Patients attend 45-minute group yoga classes
every 3 weeks on the days they are scheduled for chemotherapy for approximately 5-6
sessions. Patients are provided with a yoga DVD, a manual with photos and written
descriptions/guidance to practice yoga postures at home, and basic yoga equipment (yoga
mat, strap, block, yoga blankets) and instructed to practice to the DVD 3 times per
week (twice weekly during week of group yoga class) for ≥ 45 minutes. Patients record
yoga practice time/activity at the third yoga session of each week.
- Arm II (home yoga practice): Patients are provided with a yoga DVD, a manual with
photos and written descriptions/guidance to practice yoga postures at home, and basic
yoga equipment (yoga mat, strap, block, yoga blankets) and instructed to practice to
the DVD 3 times per week for ≥ 45 minutes. Patients record yoga practice time/activity
at the third yoga session of each week.
All patients complete questionnaires at baseline, at weeks 9, 18, and 22. Self-report
measures include Distress Thermometer, Positive and Negative Affect Schedule, Center for
Epidemiologic Studies-Depression Scale, M.D. Anderson Symptom Inventory, Functional
Assessment of Cancer Therapy - Ovarian, Functional Assessment of Chronic Illness Therapy
(FACIT) - Spiritual Subscale, FACIT- Fatigue Subscale, State-Trait Anxiety Inventory,
Women's Health Initiative Insomnia Rating Scale, Medical Outcome Study-Social Support
Survey, Integrative Medicine Use, Pre- and Post- Class Ratings, and Intervention Feedback .
After completion of study, patients are followed at 4 weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Self-reported fatigue
22 weeks
No
Suzanne C. Danhauer, PhD
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
CDR0000632845
NCT00856453
May 2009
October 2009
Name | Location |
---|---|
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |