Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer



Status:Terminated
Conditions:Ovarian Cancer, Cancer, Depression, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 120
Updated:8/11/2018
Start Date:May 2009
End Date:October 2009

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Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy

RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in
patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing
yoga in group classes is more effective than practicing yoga at home.

PURPOSE: This randomized clinical trial is studying how well yoga works in relieving fatigue
in patients undergoing chemotherapy for ovarian cancer.

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.

DISEASE CHARACTERISTICS:

- Diagnosis of ovarian cancer

- Any stage disease

- Must be between 2-24 months post-primary treatment (surgery) following initial
diagnosis and/or have a recurrence of ovarian cancer within the past 24 months
(irrespective of current treatment status)

- Began a new chemotherapy treatment regimen within the past 4 weeks or planning to
begin new chemotherapy treatment regimen within the next 4 weeks

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Physically able to attend the intervention classes

- Able to understand written and spoken English

- Agree to keep psychiatric medications and doses stable during study intervention

- No medical contraindications reported by the attending physician

- No bipolar disorder, schizophrenia, psychotic depression, or any other psychotic
disorder

- No usage of illicit drugs

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 3 months since prior yoga practice
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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mi
from
Winston-Salem, NC
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