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TerminatedNCT00856453Updated Aug 9, 2018

Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

An interventional study of Home yoga practice and yoga classes in Depression, Fatigue and Ovarian Cancer, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Why this study was terminated
slow accrual
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Female
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Depression
  • Fatigue
  • Ovarian Cancer

Keywords

  • fatigue
  • depression
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • stage I ovarian epithelial cancer
  • stage I ovarian germ cell tumor
  • stage II ovarian epithelial cancer
  • stage II ovarian germ cell tumor
  • stage III ovarian epithelial cancer
  • stage III ovarian germ cell tumor
  • stage IV ovarian epithelial cancer
  • stage IV ovarian germ cell tumor
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Yoga classes plus home yoga practic

    Behavioral: Home yoga practice · Behavioral: yoga classes

  • Experimental
    home yoga practice alone

    Behavioral: Home yoga practice

Interventions

  • BehavioralHome yoga practice

    training for and tracking of patient's practice of yoga at home

  • Behavioralyoga classes

    organized out of home classes for yoga

06

What researchers measure

Primary outcomes

  1. Self-reported fatigue

    Time frame: 22 weeks

Secondary outcomes

  1. Self-reported distress, depression, and sleep quality

    Time frame: 22 weeks

  2. Pre- and post-yoga class change in symptom/distress ratings

    Time frame: 22 weeks

  3. Yoga intervention adherence

    Time frame: 18 weeks

07

Study locations

1 site
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00856453
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 5, 2009
Start date
May 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Aug 9, 2018

Study contacts

Suzanne C. Danhauer, PhD
principal investigator · Wake Forest University Health Sciences
Brigitte E. Miller, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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