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1.
Contemp Clin Trials ; 130: 107215, 2023 07.
Article in English | MEDLINE | ID: mdl-37164298

ABSTRACT

INTRODUCTION: From diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. MATERIALS AND METHODS: We describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05414812.


Subject(s)
Breast Neoplasms , Cancer Survivors , Female , Humans , Pregnancy , Counseling , Quality of Life , Women's Health
2.
Rev Panam Salud Publica ; 17(4): 263-70, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15969978

ABSTRACT

OBJECTIVE: Elevated serum total homocysteine (tHcy) is considered an independent risk factor for cardiovascular disease. The objective of this study was to develop the first-ever information on the prevalence of hyperhomocysteinemia and its determinants in a population in Costa Rica. METHODS: A cross-sectional study was conducted to determine serum levels of tHcy, vitamin B(12), folate, and creatinine, as well as the presence of the genotype TT for the methylenetetrahydrofolate reductase (MTHFR) enzyme. Additionally, dietary vitamin intakes and other lifestyle risk factors were assessed. A total of 399 Costa Rican adults from the central valley of the country (where the capital city, San José, is located), aged 20 to 40 years, participated in this study in the year 2000. Analyses of variance were performed for continuous variables, and the chi-square test was used for categorical data. Spearman correlation tests were calculated to determine associations between variables. Three linear regression analyses and one binary logistic model were developed in order to determine the predictors for homocysteine levels in the population studied. RESULTS: The overall prevalence of hyperhomocysteinemia (>15 micromol/L) in the population was 6%, 31% of the population were in the range of 10 to 15 micromol/L, 29% had the genotype TT for the enzyme MTHFR, 18% presented a vitamin B(12) deficiency (<165 pmol/L), and none of the persons had low serum folate levels (<7.0 nmol/L). No significant associations were found between tHcy and age, smoking, consuming alcohol, or dietary vitamin intake. CONCLUSIONS: Only serum vitamin B(12) levels and the genotype TT of the enzyme MTHFR were considered significant predictors of high serum tHcy levels in the Costa Rica population studied.


Subject(s)
Cardiovascular Diseases/blood , Cardiovascular Diseases/epidemiology , Homocysteine/blood , Adult , Cardiovascular Diseases/etiology , Costa Rica , Cross-Sectional Studies , Diet , Female , Genetic Predisposition to Disease , Humans , Life Style , Male , Risk Factors
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