Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer

NCT ID: NCT00856453

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-10-31

Brief 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.

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.

Conditions

Depression; Fatigue; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga classes plus home yoga practic

Group Type: EXPERIMENTAL

Home yoga practice

Intervention Type: BEHAVIORAL

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

yoga classes

Intervention Type: BEHAVIORAL

organized out of home classes for yoga

home yoga practice alone

Group Type: EXPERIMENTAL

Home yoga practice

Intervention Type: BEHAVIORAL

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

Interventions

Home yoga practice

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

Intervention Type: BEHAVIORAL

yoga classes

organized out of home classes for yoga

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne C. Danhauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Brigitte E. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-98408

Identifier Type: -

Identifier Source: secondary_id

IRB00007745

Identifier Type: -

Identifier Source: secondary_id

CDR0000632845

Identifier Type: -

Identifier Source: org_study_id