Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00994279
First received: October 13, 2009
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.

PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.


Condition Intervention Phase
Breast Cancer
Depression
Fatigue
Sleep Disorders
Behavioral: Yoga
Behavioral: Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Yoga or Wellness Education During Breast Cancer Treatment: Establishing Community-Based Partnerships

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • Study participation rate [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Sleep quality at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Distress at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Treatment-related symptoms at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Quality of life at baseline and at weeks 5, 10, and 14 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Feedback on the yoga intervention from patients and yoga teachers [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Yoga Intervention
Yoga Intervention
Behavioral: Yoga
Yoga sessions
Active Comparator: Arm 2: Educational Wellness Group
Educational Wellness Group
Behavioral: Education
Educational Wellness Group

Detailed Description:

OBJECTIVES:

Primary

  • To estimate the participation rate, accrual, adherence, and retention to a community-based study of yoga vs an active control (wellness education) in women with stage I-III breast cancer undergoing chemotherapy.

Secondary

  • To obtain estimates of the variability of women's self-reported fatigue and depressive symptoms, sleep quality, and health-related quality of life from baseline to the end of the intervention at 10 weeks.
  • To obtain estimates of the efficacy of a community-based yoga intervention in women with breast cancer.
  • To standardize the yoga protocol for use in multiple community settings with breast cancer patients, and ascertain that yoga teachers can adhere to a uniform protocol.

OUTLINE: This is a multicenter study. Patients are stratified according to CCOP site and chemotherapy-treatment status (planning vs started). Patients are randomized to 1 of 2 intervention arms.

Patients must begin their class or group within 3 weeks of starting chemotherapy. All women enter their class or group on a rolling basis so that their class or group coincides with the weeks that they receive chemotherapy treatments.

  • Arm I (Yoga intervention): In weeks 1-10, patients attend a community-based weekly 75-minute Integral Yoga class led by an experienced yoga teacher specifically trained in adapting yoga for people with cancer. The yoga class includes postures, deep relaxation, breathing practices, and meditation to create a profound experience of peace and well-being. Women are asked to attend ≥ 8 of 10 classes over a 12-week period to allow for missed classes. Women are also provided with a yoga mat, associated yoga props (bolster, strap), and a 45-minute cancer-specific yoga DVD for home practice. Women are asked to practice yoga outside of the class at least twice per week, and are encouraged to practice more frequently than that.
  • Arm II (Active control): Patients meet for a weekly 75-minute wellness education group in weeks 1-10 (women may make-up missed classes during weeks 11 and 12). The group focuses on issues that women with breast cancer face as they undergo treatment; topics include symptom management, financial and insurance issues, emotional issues/coping with cancer, communicating with healthcare providers/navigating the healthcare system, healthful eating/cooking demonstrations, sexual issues/fertility/body image, mobilizing social support/impact of cancer on family and friends, survivorship (advocacy) opportunities, and common concerns/fear of recurrence. Women are provided with reading materials relevant to the topics that will be covered in each group meeting and are asked to spend approximately 45 minutes twice weekly reading these materials and incorporating any relevant principles/ideas into their daily lives. Women may request additional reading materials in further topics of interest from the group facilitators.

Patients complete questionnaires at baseline and at weeks 5, 10, and 14 to assess fatigue (FACIT-Fatigue), depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D]), treatment-related symptoms (M.D. Anderson Symptom Inventory [MDASI]), sleep disturbance (Medical Outcomes Study Sleep Measure [MOS-Sleep]), and health-related quality of life (Functional Assessment of Cancer Therapy-Breast [FACT-B]). Patients also track time spent on all home-yoga practice (arm I) or wellness-group homework (arm II). After the intervention (week 10), patients are asked to provide feedback on the program. Yoga/Wellness teachers will completion intervention feedback forms 6 months from the start of the first intervention and at completion of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women will be eligible if they are:

  • Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.
  • ≥18 years of age.
  • Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).
  • Diagnosed with breast cancer Stages I-III.
  • Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
  • 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
  • Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).
  • Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
  • Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.

Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994279

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Principal Investigator: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT00994279     History of Changes
Other Study ID Numbers: CCCWFU97309, U10CA081851
Study First Received: October 13, 2009
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
fatigue
depression
sleep disorders
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Sleep Disorders
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

ClinicalTrials.gov processed this record on April 14, 2014