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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AT005340-03 | U.S. NIH Grant/Contract | View source |
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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 determine whether a four-month manualized Ayurvedic intervention will improve quality of life 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. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop 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 |
|---|---|---|---|
| Ayurvedic Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized manualized Ayurvedic intervention | Behavioral | The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life over 16 weeks | The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms. | Baseline, End of week 8, End of week 16 |
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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 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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