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Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy


N/A
18 Years
N/A
Not Enrolling
Female
Depression, Fatigue, Ovarian Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Self-reported fatigue

Outcome Time Frame:

22 weeks

Safety Issue:

No

Principal Investigator

Suzanne C. Danhauer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000632845

NCT ID:

NCT00856453

Start Date:

May 2009

Completion Date:

October 2009

Related Keywords:

  • Depression
  • Fatigue
  • Ovarian Cancer
  • 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
  • Depression
  • Depressive Disorder
  • Fatigue
  • Ovarian Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096