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

NCT00994279 | Completed Results DMC

• 3 other identifiers: IRB00011383U10CA081851REBACCCWFU97309
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Depression; Fatigue; Sleep Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Retention

  Proportion of participants completing the 10 week study

  10 weeks

Secondary Outcomes (1)

• Fatigue at 10 Weeks

  10 weeks

Study Arms (2)

Arm 1: Yoga Intervention

ACTIVE COMPARATOR

Yoga Intervention

Behavioral: Yoga

Arm 2: Educational Wellness Group

ACTIVE COMPARATOR

Educational Wellness Group

Behavioral: Education

Interventions

Yoga BEHAVIORAL

Yoga sessions

Arm 1: Yoga Intervention

Education BEHAVIORAL

Educational Wellness Group

Arm 2: Educational Wellness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Fatigue; Sleep Wake Disorders

Interventions

Yoga; Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

There were no limitations.

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest NCI NCORP Research Base

dcase@wakehealth.edu

(336) 716-1048

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: January 1, 2010
• Primary Completion: October 14, 2011
• Study Completion: October 14, 2011
• Last Updated: October 20, 2021
• Results First Posted: March 9, 2017

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)