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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.
The study uses a single-arm design. All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up). Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition | Experimental | Questionnaires and yoga classes. Group will attend a series of 90-minute yoga classes twice a week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Participants will be asked to complete a set of questionnaires about their health and well-being on two occasions (baseline and follow-up). Each set of questionnaires will take about 45 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Study Enrollment | Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate. | 24 months |
| Rate of Study Completion | Feasibility of the proposed study assessment and intervention methods. The study methods will be considered feasible if 70% or more of consented participants complete both the baseline and follow-up assessments and attend an average of 70% or more of scheduled yoga classes. | Up to 24 weeks per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Reduced Pain Severity | Potential efficacy of the intervention in relieving AI medication-associated joint pain. The intervention will be considered potentially efficacious in relieving AI medication-associated joint pain if comparisons of pre- and post-intervention means for one or more measures of pain severity yield an effect size >/= 0.3 consistent with pain reduction. | Up to 24 weeks per participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Jacobsen, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002277 | Carcinoma |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015013 | Yoga |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Yoga Classes | Other | Iyengar yoga is a traditional form of Hatha yoga that has been used previously to address quality of life issues in women with breast cancer. Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). |
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| Occurrence of Relief from Other Side Effects | Potential efficacy of the intervention in relieving other reported side effects of AI medication (i.e., fatigue, hot flashes, sleep problems, and depressive symptoms). The intervention will be considered potentially efficacious in relieving other known side effects if comparisons of pre- and post-intervention means yield an effect size >/= 0.3 consistent with side effect reduction. | Up to 24 weeks per participant |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |