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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.
Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to refine the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Medicine Intervention | Experimental | Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Integrative Medicine Intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life over 12 months | The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms. | Baseline, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue over 12 months | The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue. | Baseline, 3 months, 6 months, 12 months |
| Change in sleep quality over 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Dhruva, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
| Baseline, 3 months, 6 months, 12 months |
| Change in anxiety over 12 months | The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety. | Baseline, 3 months, 6 months, 12 months |
| Change in depressive symptoms over 12 months | The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms. | Baseline, 3 months, 6 months, 12 months |
| Change in pain over 12 months | The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function. | Baseline, 3 months, 6 months, 12 months |
| Change in diet over 12 months | The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period. | Baseline, 3 months, 6 months, 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |