An interventional study of Individualized Integrative Medicine Intervention in Breast Cancer, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Individualized Integrative Medicine Intervention
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.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in fatigue over 12 months
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in sleep quality over 12 months
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, 12 months
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco