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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01402 | Registry Identifier | NCI, Clinical Trials Reporting Program |
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Insufficient staff and funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
PRIMARY OBJECTIVES:
I. To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema.
II. To identify and document required modifications for a safe and feasible practice.
III. To obtain recruitment estimates and determine barriers to recruitment (acceptability).
IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.
V. To establish safety. VI. To assess satisfaction. VII. To determine the preliminary efficacy of a modified yoga program for lymphedema in BCS, and associated physical and psychological symptoms/symptom burden, and overall health status.
OUTLINE:
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes.
3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (Yoga) | Experimental | Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Procedure | Complete guided and home yoga sessions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pose Modifications | number of poses requiring modifications as indicated in the modification form | Up to 8 weeks |
| Assess safety | Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0 | Up to 8 weeks |
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Inclusion Criteria:
Lymphedema Group:
No Lymphedema Group:
Exclusion Criteria (Both Groups):
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| Name | Affiliation | Role |
|---|---|---|
| Sheila Ridner, PhD, RN | Vanderbilt University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University School of Nursing | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| tape measurement of arm |
| Other |
Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| ldex measurement of arms | Other |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |