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Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Terminated

Conditions

Depression
Ovarian Cancer
Fatigue

Treatments

Behavioral: yoga classes
Behavioral: Home yoga practice

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00856453
CCCWFU-98408
CDR0000632845
IRB00007745

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Yoga classes plus home yoga practic
Experimental group
Treatment:
Behavioral: Home yoga practice
Behavioral: yoga classes
home yoga practice alone
Experimental group
Treatment:
Behavioral: Home yoga practice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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