PURPOSE:To compare disease free survival experienced by women who received usual oncologic care compared to a cohort of women who received naturopathic oncology care in addition to usual care. METHODS:Women with breast cancer who received naturopathic oncology (NO) care in Western Washington State (WA) (N = 176) were recruited to a prospective study of clinical health-related quality of life outcomes and then matched to women who received usual care (UC) only (N = 334). RESULTS:Among 510 women with breast cancer stages 1 to 3, a total of 50 women (10%) experienced a disease-free survival (DFS) ending event within the observation period; 23 (6.8% of those in the UC cohort, and 27 (15.3% of those in the NO cohort (P < .05). Although, women in the 2 cohorts received similar surgical, chemotherapy, and radiation treatment, women with breast cancer who received naturopathic oncology adjunctive care were less likely to use anti-estrogen therapy, and experienced poorer DFS (logrank test, P < .05). However, differences in DFS could not be shown to be due to cohort differences in anti-estrogen therapy, baseline HRQOL, or naturopathic oncology therapies prescribed. The stage 3 women in the naturopathic oncology group had more advanced disease at diagnosis. They were more likely to have 5 or more metastatic lymph nodes at baseline (18.5%) compared to their usual care matched control group (13%). Women in the naturopathic oncology group also had higher grade tumors at diagnosis. CONCLUSIONS:Results show that recurrence of breast cancer was associated with more advanced malignant lymph node involvement; and that naturopathic oncology services provided in 2009-2015 did not improve disease-free survival in these high-risk breast cancer patients.

An important need exists to better understand and stratify kidney disease according to its underlying pathophysiology in order to develop more precise and effective therapeutic agents. National collaborative efforts such as the Kidney Precision Medicine Project are working towards this goal through the collection and integration of large, disparate clinical, biological and imaging data from patients with kidney disease. Ontologies are powerful tools that facilitate these efforts by enabling researchers to organize and make sense of different data elements and the relationships between them. Ontologies are critical to support the types of big data analysis necessary for kidney precision medicine, where heterogeneous clinical, imaging and biopsy data from diverse sources must be combined to define a patient's phenotype. The development of two new ontologies - the Kidney Tissue Atlas Ontology and the Ontology of Precision Medicine and Investigation - will support the creation of the Kidney Tissue Atlas, which aims to provide a comprehensive molecular, cellular and anatomical map of the kidney. These ontologies will improve the annotation of kidney-relevant data, and eventually lead to new definitions of kidney disease in support of precision medicine. Ontologies are powerful tools that facilitate the integration of large and disparate data sets. Here, researchers from the Kidney Precision Medicine Project provide an introduction to ontologies, including those developed by the consortium, describing how these will be used to improve the annotation of kidney-relevant data, eventually leading to new definitions of kidney disease in support of precision medicine.

Background: Vitamin D supplements may prevent recurrence, prolong survival, and improve mood for women with breast cancer, although evidence for these effects is preliminary. Methods: This report describes vitamin D supplement use by 553 breast cancer patient/survivors (193 who used a naturopathic oncology [NO] provider and 360 who did not) participating in a matched cohort study of breast cancer outcomes. Results: We found that more than half of breast cancer patients reported using vitamin D supplements. Women who received care from NO providers in early survivorship may be more likely to use vitamin D supplements ( P < .05). Approximately 30% of breast cancer patients with blood levels recorded in their medical chart were potentially vitamin D deficient (<30 ng/mL). Vitamin D supplement use at study enrollment was associated with higher levels of self-reported health-related quality of life (HRQOL) at enrollment ( P < .05) and predicted better HRQOL at 6-month follow-up ( P < .05). Sufficient blood levels of vitamin D recorded between enrollment and follow-up were also associated with better HRQOL at follow-up ( P < .05). Conclusions: Vitamin D supplementation by breast cancer patients is common both during and after treatment for breast cancer, but deficiency may also be common. NO and conventional providers may be able to promote vitamin D sufficiency through vitamin D supplementation and by encouraging healthy solar exposure. Further studies should be undertaken examining whether vitamin D supplementation and higher blood levels might improve HRQOL among women with breast cancer in early survivorship.

Consortia conducting precision medicine studies face a major challenge of integrating big data including clinical and biomedical data. In this study, we report our development of the community-driven Ontology of Precision Medicine and Investigation (OPMI) and its applications in clinical data and metadata representation. OPMI has been used to represent the common data model (CDM) of the Observational Health Data Sciences and Informatics (or OHDSI) program. It has also been used to represent approximately 30 case report forms defined by the NIH-supported Kidney Precision Medicine Project (KPMP). Our case studies showed that OPMI is able to semantically and precisely represent the OHDSI CDM, various KPMP clinical forms, and their associated data and metadata. Such ontological representations support standardized data representation, sharing, recording, integration, and advanced analysis. Keywords— Common data model; kidney; case report form.

Objective: This study sought to describe changes in the health-related quality of life (HRQOL) of women who do and do not seek naturopathic oncology (NO) complementary and alternative medicine (CAM) care during and immediately after breast cancer treatment, and to explore the predictive role of NO CAM care, demographic characteristics, and involvement in decision-making on HRQOL in breast cancer survivors. Methods: Matched cohorts of breast cancer survivors who did and did not choose to supplement their breast cancer treatment with NO care within 2 years of diagnosis participated. NO users were identified through naturopathic doctors' clinics and usual care (UC) controls with similar prognosis were identified through a cancer registry. The registry provided information about all participants' age, race, ethnicity, marital status, stage of cancer at time of diagnosis, date of diagnosis, and use of conventional medical treatments (surgery, chemotherapy, radiation, and endocrine therapy). Data of participants' self-reported involvement in decision-making and HRQOL were collected at study enrollment and at 6-month follow-up. Results: At 6-month follow-up, the NO patients reported significantly more involvement in decision-making about care and better general health than did UC patients (P < .05). Self-reported involvement in decision-making about cancer treatment was associated with better role-physical, role-emotional, and social-functional well-being (P < .05). Race, age, marital status, and congruence of preferred and achieved levels of involvement also predicted aspects of HRQOL in breast cancer survivors (P < .05). Conclusions: Both NO CAM care and involvement in decision-making about cancer treatment may be associated with better HRQOL in breast cancer survivors.

Purpose: To determine if women with breast cancer who choose adjunctive naturopathic oncology (NO) specialty care receive different standard oncologic treatment when compared with breast cancer patients who receive only standard care. Participants: Women with breast cancer stages 0 to 4, aged 18+ who spoke English and sought care from outpatient naturopathic doctor clinics were enrolled in an observational study of clinical and quality of life outcomes. Women who sought NO care 2 or more times within the first 2 years postdiagnosis were identified as NO cases. A matched comparison group of breast cancer patients were identified using the Western Washington Cancer Surveillance System(CSS). Methods: A longitudinal cohort design. In addition to self-report data, the CSS provided data on demographics, stage at the time of diagnosis, and initial treatment. Oncology medical records were abstracted in order to provide additional information on standard oncologic treatment for all participants. Results: Cohorts were well matched with regard to demographic, histologic, and prognostic indicators at the time of diagnosis. Approximately 70% of women in both cohorts received standard oncologic care that met the National Comprehensive Cancer Network guidelines. There were no statistically significant differences between the cohorts in treatment received. Fewer women in the NO cohort with estrogen receptor–positive breast cancer appear to have received antiestrogen therapy. Conclusions: Women in both cohorts appear to receive guideline-concordant care. However, women who receive adjunctive NO care may be less likely to receive antiestrogen therapy.

Background. Naturopathic oncology in conjunction with conventional treatment is commonly referred to as integrative oncology (IO). Clinics directed by oncology board certified NDs (Fellows of the American Board of Naturopathic Oncology or FABNOs) provide high-quality data for describing IO therapies, their costs and measuring clinical outcomes. Purpose. To describe the types of IO therapies prescribed to breast cancer patients by ND FABNO physicians. Study participants (n = 324). Women who sought care at 1 of 6 naturopathic oncology clinics in Washington State were asked to enroll in a prospective 5 year observational outcomes study. Methods. Medical records were abstracted to collect treatment recommendations and cost data. Results. More than 72 oral or topical, nutritional, botanical, fungal and bacterial-based medicines were prescribed to the cohort during their first year of IO care. Trametes versicolor was prescribed to 63% of the women. Mind-body therapy was recommended to 45% of patients, and 49% received acupuncture. Also, 26% were prescribed injectable therapy, including mistletoe, vitamin B complex (12%), IV ascorbate (12%), IV artesunate (7%), and IV nutrition and hydration (4%). Costs ranged from $1594/year for early-stage breast cancer to $6200/year for stage 4 breast cancer patients. Of the total amount billed for IO care for 1 year for breast cancer patients, 21% was out-of-pocket. Conclusions. IO care for women with breast cancer consists of botanical and mushroom oral therapies, parenteral botanical and nutrient therapy, mind-body medicine and acupuncture. IO clinic visits and acupuncture are partially paid for by medical insurance companies.

Objective. While many Complementary and Alternative Medicines (CAM) are unlikely to interact negatively with conventional oncology treatment, some ingestible CAM substances have biological activities that may reduce the effectiveness of chemotherapy or radiation. This study surveyed women with breast cancer in order to document the extent to which women with breast cancer use these CAM substances of concern concurrently with conventional treatments. Methods. A total of 398 women completed a survey describing their use of CAM at various time points in their cancer treatment. This report focuses on a subsample of 250 women receiving chemotherapy or radiation who reported using specific one or more of several chemotherapies. Results. Of those participating, 104 (43.7%) of those receiving chemotherapy (n = 238) and 45 (32.3%) of those receiving radiation (139; 58.4% of all patients) reported using one or more CAM substances that could be cause for concern when taken concurrently. Conclusion. Research is needed to understand the real risks associated with CAM and conventional polypharmacy. If risks associated with CAM conventional polypharmacy use prove to be substantial then improved systems to assure all women get advice regarding herb and supplement use during breast cancer treatment appear to be needed.