Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Retention [10 weeks]
Proportion of participants completing the 10 week study
Secondary Outcome Measures
- Fatigue at 10 Weeks [10 weeks]
FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Edward G. Shaw, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00011383
- U10CA081851
- REBACCCWFU97309
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from three NCI CCOP sites between 1/2010 and 8/2011 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group |
|---|---|---|
| Arm/Group Description | Yoga Intervention Yoga: Yoga sessions | Educational Wellness Group Education: Educational Wellness Group |
| Period Title: Overall Study | ||
| STARTED | 22 | 18 |
| COMPLETED | 18 | 13 |
| NOT COMPLETED | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group | Total |
|---|---|---|---|
| Arm/Group Description | Yoga Intervention Yoga: Yoga sessions | Educational Wellness Group Education: Educational Wellness Group | Total of all reporting groups |
| Overall Participants | 22 | 18 | 40 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
19
86.4%
|
18
100%
|
37
92.5%
|
| >=65 years |
3
13.6%
|
0
0%
|
3
7.5%
|
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
50
|
45
|
47
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
22
100%
|
18
100%
|
40
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
22
100%
|
18
100%
|
40
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
9.1%
|
3
16.7%
|
5
12.5%
|
| White |
20
90.9%
|
15
83.3%
|
35
87.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
22
100%
|
18
100%
|
40
100%
|
Outcome Measures
| Title | Retention |
|---|---|
| Description | Proportion of participants completing the 10 week study |
| Time Frame | 10 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants |
| Arm/Group Title | Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group |
|---|---|---|
| Arm/Group Description | Yoga Intervention Yoga: Yoga sessions | Educational Wellness Group Education: Educational Wellness Group |
| Measure Participants | 22 | 18 |
| Number (95% Confidence Interval) [percentage of participants] |
82
372.7%
|
89
494.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm 1: Yoga Intervention, Arm 2: Educational Wellness Group |
|---|---|---|
| Comments | Null hypothesis is that the two arms will not differ in retention at 14 weeks. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .53 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Fatigue at 10 Weeks |
|---|---|
| Description | FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue. |
| Time Frame | 10 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study. |
| Arm/Group Title | Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group |
|---|---|---|
| Arm/Group Description | Yoga Intervention Yoga: Yoga sessions | Educational Wellness Group Education: Educational Wellness Group |
| Measure Participants | 18 | 15 |
| Least Squares Mean (Standard Error) [units on a scale] |
30.2
(2.6)
|
30.1
(2.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm 1: Yoga Intervention, Arm 2: Educational Wellness Group |
|---|---|---|
| Comments | Null hypothesis is that the two groups would not differ in fatigue at 10 weeks. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .98 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | 14 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit. | |||
| Arm/Group Title | Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group | ||
| Arm/Group Description | Yoga Intervention Yoga: Yoga sessions | Educational Wellness Group Education: Educational Wellness Group | ||
All Cause Mortality |
||||
| Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/21 (4.8%) | 1/17 (5.9%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Cardiac disorders | ||||
| Heart Failure | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Arm 1: Yoga Intervention | Arm 2: Educational Wellness Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/21 (52.4%) | 8/17 (47.1%) | ||
| Gastrointestinal disorders | ||||
| Mucositis oral | 1/21 (4.8%) | 2 | 1/17 (5.9%) | 1 |
| Nausea | 2/21 (9.5%) | 3 | 0/17 (0%) | 0 |
| General disorders | ||||
| Fatigue | 3/21 (14.3%) | 6 | 2/17 (11.8%) | 4 |
| Myalgia | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 2 |
| Pain | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infections and infestations | ||||
| Infections and Infestations | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Peripheral nerve infection | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Urinary tract infection | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 5/21 (23.8%) | 5 | 3/17 (17.6%) | 3 |
| Musculoskeletal/Soft tissue = Cartilage Tears | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Neck Pain | 2/21 (9.5%) | 3 | 2/17 (11.8%) | 2 |
| Nervous system disorders | ||||
| Pain in Extremity | 8/21 (38.1%) | 12 | 4/17 (23.5%) | 5 |
| Peripheral sensory neuropathy | 2/21 (9.5%) | 3 | 0/17 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Sore Throat | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Palmar-plantar erythrodysesthesia syndrome | 0/21 (0%) | 0 | 1/17 (5.9%) | 2 |
| Rash acneiform | 2/21 (9.5%) | 3 | 0/17 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Doug Case |
|---|---|
| Organization | Wake Forest NCI NCORP Research Base |
| Phone | (336) 716-1048 |
| dcase@wakehealth.edu |
- IRB00011383
- U10CA081851
- REBACCCWFU97309