Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

Depression Clinical Trial

Official title:

Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00856453
• Other study ID #: CDR0000632845
• Secondary ID: CCCWFU-98408IRB0
• Status: Terminated
• Phase: N/A
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Fatigue
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Home yoga practice
training for and tracking of patient's practice of yoga at home
• yoga classes
organized out of home classes for yoga

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported fatigue		22 weeks
Secondary	Self-reported distress, depression, and sleep quality		22 weeks
Secondary	Pre- and post-yoga class change in symptom/distress ratings		22 weeks
Secondary	Yoga intervention adherence		18 weeks