Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Carcinoma
Conditions
Keywords
Complementary and Alternative Medicine, Alternative medicine, Herbs, Supplements, Complementary therapies, Holistic health
Brief summary
This research study is enrolling participants diagnosed with breast cancer and receiving/received chemotherapy and/or endocrine therapy. The study's primary objective is to assess the differences in the use of herbs and supplements among the populations served at Cleveland Clinic Florida and Ohio by administering a participant-reported questionnaire.
Detailed description
The world has seen a rise in the use of Complementary and Alternative Medicine (CAM) since the early 1980s. This interest in CAM was significant in the United States to the extent that Congress established and set the Dietary Supplement Health and Education Act of 1994 to define what a dietary supplement entails and to launch a legal framework that oversees these products. In 2020, the National Health and Nutrition Examination survey found that the prevalence of dietary supplements among adults was around 58.5%, with sales reaching $55.7 Billion. Notably, the consumption of dietary supplements is not limited to healthy individuals. Individuals with cancer are significant consumers of such products, with a prevalence rate as high as 50% in the United States. CAM use originates from traditional and cultural practices outside of the Western healthcare system. The literature on the association between CAM use and ethnicity presents conflicting data. Most of the available studies are old, dating to the early 2000s, and lack proper ethnic representation. Additionally, there is a notable gap in the literature regarding the utilization of CAM in breast cancer patients within ethnic minorities. This study aims to evaluate ethnicity and its influence on the use of herbs and supplements in early-stage breast cancer (Stages 1,2,3) in two populations: participants receiving care at Cleveland Clinic Florida and those receiving care at Cleveland Clinic Ohio. The investigators also aim to evaluate the interactions between the most used herbs and supplements with standard therapy, be it endocrine therapy or chemotherapy. The investigators will select the top 10 by frequency of the used herbs and supplements and cross-match it with the Memorial Sloan Kettering Cancer Center integrative medicine "Search about Herbs" (https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs/search) as well as "Herbs at glance" via the NIH website (https://www.nccih.nih.gov/health/herbsataglance). Moreover, the investigators aim to determine the prevalence of herbs and supplements use in individuals with breast cancer.
Interventions
OTHERNo intervention
Participants will complete a one-time 33-question survey. The survey is comprised of three sections: (1) Section A includes 12 questions related to demographic information, (2) Section B consists of 2 questions addressing treatment characteristics, \& (3) Section C contains 19 questions focusing on supplement usage.
Sponsors
Case Comprehensive Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 18 years and older. * Breast cancer diagnosis at pathologic stage (I, II, and III) * Participants with regional lymph node involvement * Received Chemotherapy and/ or Endocrine therapy * Established patients followed by a medical oncologist at Cleveland Clinic Florida and Ohio * Able and willing to participate in the one-time survey.
Exclusion criteria
* Under 18 years of age * Prior history of cancer diagnosis * Unable or unwilling to participate in the survey * Distant Metastatic Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of ethnicity on herb/supplement usage among early stage breast cancer participants. | 5 months | Univariate analysis in which Chi-square test or Fisher's exact test will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the ten most common herbs and supplements by frequency of use in each Cancer Center. | 5 months | — |
| Determine the Prevalence of Herbs and Supplements in breast cancer patients. | 5 months | — |
| Assess potential associations between Conventional treatments and Herbs/Supplements. | 5 months | Measured by multiple logistic regression model |
| Association between cancer stage and herbs/supplement usage. | 5 months | Measured by multiple logistic regression model |
Countries
United States
Contacts
CONTACTElizabeth Stone, MD
PRINCIPAL_INVESTIGATORElizabeth Stone, MD
Case Comprehensive Cancer Center, Cleveland Clinic Florida
Outcome results
None listed