Uptake of Risk-Reducing Measures, Cascade Testing, and Related Challenges Among Carriers of Breast Cancer-Associated Germline Pathogenic Variants in Mexico.

PURPOSE: Genetic cancer risk assessment (GCRA) provides pathogenic variant (PV) carriers with the invaluable opportunity to undertake timely cancer risk-reducing (RR) measures and initiate cascade testing (CT). This study describes the uptake of these strategies and the related barriers among breast cancer-associated germline PV carriers in Mexico. METHODS: Carriers who were at least 6 months after disclosure of genetic test results at two GCRA referral centers were invited to answer a survey assessing sociodemographic characteristics, awareness of their carrier status and its implications, uptake of RR measures according to international guidelines by PV, CT initiation, and associated challenges. RESULTS: Of the eligible carriers, 246/384 (64%) answered the survey (median age: 44 years). Most were female (88%), married/in domestic partnership (66%), and had personal breast/ovarian cancer history (61%). PVs included BRCA1/2 (75%), CHEK2 (10%), PALB2 (5%), ATM (5%), NF1 (2%), RAD51C (2%), PTEN (1%), and TP53 (1%). Most (87%) participants were aware of their carrier status. When recommended, 37% underwent RR bilateral mastectomy, 48% RR oophorectomy, 70% annual mammogram, and 20% breast magnetic resonance imaging. Challenges hindering the uptake of RR measures included financial limitations (67%), lack of recommendation by their physician (35%), and fear (24%). Nearly all (98%) claimed sharing their results with their relatives. CT was initiated in 63% of families and was associated with carriers being married/in domestic partnership (P = .04) and believing GCRA was useful (P < .001). CONCLUSION: Despite the resource-constrained setting, relevant rates of RR measures and CT were observed. Targeted interventions to reduce out-of-pocket expenses and improve patient-physician communication and patients' understanding on carrier status are warranted to enhance the overall benefit of GCRA and ultimately improve the provision of patient-centered care to both carriers and their at-risk relatives.

The Efficacy and Usability of an Unguided Web-Based Grief Intervention for Adults Who Lost a Loved One During the COVID-19 Pandemic: Randomized Controlled Trial.

BACKGROUND: The death of a loved one was a challenge many people faced during the COVID-19 pandemic within the context of extraordinary circumstances and great uncertainty. Grief is an unavoidable part of life, and for most people, feelings of grief decrease naturally over time. However, for some people, grieving can become a particularly painful process with clinical symptoms that may require professional help to resolve. To provide psychological support to people who had lost a loved one during the COVID-19 pandemic, an unguided web-based psychological intervention was developed. OBJECTIVE: The main objective of this study was to evaluate the efficacy of the web-based treatment, Grief COVID (Duelo COVID in Spanish; ITLAB), in reducing clinical symptoms of complicated grief, depression, posttraumatic stress, hopelessness, anxiety, and suicidal risk in adults. The secondary aim was to validate the usability of the self-applied intervention system. METHODS: We used a randomized controlled trial with an intervention group (IG) and a waitlist control group (CG). The groups were assessed 3 times (before beginning the intervention, upon completing the intervention, and 3 months after the intervention). The intervention was delivered on the web in an asynchronous format through the Duelo COVID web page. Participants created an account that could be used on their computers, smartphones, or tablets. The evaluation process was automated as part of the intervention. RESULTS: A total of 114 participants were randomly assigned to the IG or CG and met criteria for inclusion in the study (n=45, 39.5% completed the intervention and n=69, 60.5% completed the waitlist period). Most participants (103/114, 90.4%) were women. The results indicated that the treatment significantly reduced baseline clinical symptoms in the IG for all variables (P<.001 to P=.006), with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥0.5). The follow-up evaluation showed that symptom reduction was maintained at 3 months after the intervention. The results from the CG showed that participants experienced significantly decreased levels of hopelessness after completing the time on the waitlist (P<.001), but their suicidal risk scores increased. Regarding the usability of the self-applied intervention system, the results indicated a high level of satisfaction with the Grief COVID. CONCLUSIONS: The self-applied web-based intervention Grief COVID was effective in reducing symptoms of anxiety, depression, hopelessness, risk of suicide risk, posttraumatic stress disorder, and complicated grief disorder. Grief COVID was evaluated by the participants, who reported that the system was easy to use. These results affirm the importance of developing additional web-based psychological tools to help reduce clinical symptoms in people experiencing grief because of the loss of a loved one during a pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04638842; https://clinicaltrials.gov/ct2/show/NCT04638842.

Improving Collection of Real-World Data: The Experience of the Joven & Fuerte Prospective Cohort for Mexican Young Women With Breast Cancer.

The prospective collection of clinical data can generate detailed information on heterogeneous populations. This article reviews the strengths and limitations of the collection of real-world data and provides insight into the feasibility of routine collection of high-quality evidence even in a resource-constrained setting. The acquisition of high-quality data to assess the clinical and psychosocial needs of young Mexican patients with breast cancer has been enhanced through the use of preplanned, standardized data definitions and instrumentation to provide internally and externally comparable results, optimization of data collection with web-based surveys, engagement of participants to minimize missing data, and routine review for data consistency. A similar approach by other research groups could improve the quality of real-world data and accomplish enhanced inference of information.

Young Women With Breast Cancer in Mexico: Results of the Pilot Phase of the Joven & Fuerte Prospective Cohort.

PURPOSE: The pilot-phase report of the Joven & Fuerte prospective cohort broadly characterizes and assesses the needs of Mexican young women with breast cancer (YWBC). PATIENTS AND METHODS: Women age ≤ 40 years with nonmetastatic primary breast cancer were consecutively accrued from 2 hospitals. Data were collected at the first/baseline oncology visit and 2 years later using a sociodemographic survey, European Organisation for Research and Treatment of Cancer Quality-of-Life (QOL) Questionnaire Core 30 (QLQ-C30) and Breast Cancer-Specific QOL Questionnaire (QLQ-BR23), Hospital Anxiety and Depression Scale (HADS), Female Sexual Functioning Index (FSFI), Sexual Satisfaction Inventory, and patients' medical records. Pearson χ2 and 2-sided t tests were used for statistical analysis. An unadjusted P value < .05 was considered significant. RESULTS: Ninety patients were included, all with government health care coverage. Most had low monthly household incomes (98%) and at least a high school education (59%). There was a considerable prevalence of unpartnered patients (36%) and unmet parity (25%). Patients' most common initial symptom was a palpable mass (84%), and they were most frequently diagnosed with stage III disease (48%), with 51% having had a physician visit ≤ 3 months since detection but 39% receiving diagnosis > 12 months later. At baseline, 66% of patients were overweight/obese, and this proportion had significantly increased by 2 years (P < .001). Compared with baseline, global QLQ-C30 had improved significantly by 2 years (P = .004), as had HADS-Anxiety (P < .001). However, both at baseline and at 2 years, nearly half of patients exhibited FSFI sexual dysfunction. CONCLUSION: These preliminary findings demonstrate that YWBC in Mexico have particular sociodemographic and clinicopathologic characteristics, reinforcing the necessity to further describe and explore the needs of these young patients, because they may better represent the understudied and economically vulnerable population of YWBC in limited-resource settings.

Patients' satisfaction with a supportive care program for young breast cancer patients in Mexico: Joven & Fuerte supports patients' needs and eases their illness process.

OBJECTIVE: The aim of this study was to evaluate patients' outlook and satisfaction with "Joven & Fuerte: Program for Young Women with Breast Cancer (YWBC) in Mexico" (J&F) and to determine its strengths and areas of improvement to better fulfill patients' information and supportive care needs. METHODS: Patients enrolled in J&F for ≥ 6 months at three cancer referral centers were invited via a messaging application to anonymously complete an online survey exploring their perspectives of the program's information delivery, support services, and research component. Descriptive statistics, chi2 test, Student t, and ANOVA were used for analysis. RESULTS: Of 484 eligible patients, 28% completed the survey. The program overall was useful/very useful according to 97% and aided 82% to better cope with their illness. The timing, clarity, and usefulness of the information provided were each described as good/very good by ≥ 83% for the written format and ≥ 98% for the verbal one. Eighty-four percent of patients were very satisfied (≥ 9/10) with psychological support and genetic assessment. The number of support services used was significantly associated with patients' perception of J&F's usefulness. Regarding fertility issues, 45% recalled being informed about preservation strategies and J&F financially supported 27/39 of interested patients. Fifty-eight percent were unaware of J&F's ongoing research component. CONCLUSIONS: Patients' satisfaction with J&F is very high, reflecting that the program is meeting Mexican YWBC's needs by providing useful information means and support services in a limited-resource setting. Efforts must keep up to guarantee the program's continuity and advocate for its extension to other oncologic centers.

Medical and information needs among young women with breast cancer in Mexico.

OBJECTIVE: To describe clinical and information needs, identify unmet support services and guide interventions for young breast cancer (BC) patients in Mexico. METHODS: Cross-sectional, qualitative study, using interpretive description methodology. Patients with initial BC diagnosis within 6-12 months prior to enrolment, ≤40 years old and literate were included in focus groups. RESULTS: Twenty-nine patients were included. Expressed needs were classified into the following categories: (a) understanding diagnosis and treatment; (b) treatment side effects; and (c) time, source and communication means. Patients felt their medical team did not provide enough information regarding diagnosis, treatment and relevant side effects related to fertility, menopause and sexuality. Lack of information fuelled uncertainty, distress, anxiety and fear, and could negatively influence treatment decisions. Patients wished that news be communicated considering their own attitude regarding the disease and providing psychological support when necessary, including partners, relatives and friends. They recommended that information should be delivered with an empathic and personalised approach, with take-home educational material to help them recall, comprehend and/or expand verbal information received during medical appointments. CONCLUSIONS: This study provides valuable insight to increase attention on unmet needs of young BC patients and to improve doctor-patient communication to ensure better care.

Psychological Impact of Alterations in Sexuality, Fertility, and Body Image in Young Breast Cancer Patients and Their Partners.

Young women with breast cancer have age-specific concerns regarding changes in sexuality, fertility, and body image. However, the psychological impact of BC and its treatments is not exclusive to young patients and it also affects their social context, especially their partners, as they experience higher illness intrusiveness than the partners of older women. In young BC patients, relationships, body image, and sexual problems are related to most quality of life domains. While BC treatment is being planned, all women should be informed about the possible side-effects of treatment on sexuality, fertility, and body image. Inclusion of partners into decision making should be pursued to restore, improve, and maintain effective communication and positive relationships in young couples facing BC. The aim of this review is to describe the psychological impact of alterations in sexuality, fertility, and body image in young BC patients and their partners, and to recommend strategies to address such issues in a timely manner.

"Joven & Fuerte": Program for Young Women with Breast Cancer in Mexico - Initial Results.

Despite the high rates of breast cancer among young Mexican women, their special needs and concerns have not been systematically addressed. To fulfill these unsatisfied demands, we have developed "Joven & Fuerte: Program for Young Women with Breast Cancer in Mexico," the first program dedicated to the care of young breast cancer patients in Latin America, which is taking place at the National Cancer Institute of Mexico and the two medical facilities of the Instituto Tecnológico y de Estudios Superiores de Monterrey. The program was created to optimize the complex clinical and psychosocial care of these patients, enhance education regarding their special needs, and promote targeted research, as well as to replicate this program model in other healthcare centers across Mexico and Latin America. From November 2013 to February 2017, the implementation of the "Joven & Fuerte" program has delivered specialized care to 265 patients, through the systematic identification of their particular needs and the provision of fertility, genetic, and psychological supportive services. Patients and families have engaged in pedagogic activities and workshops and have created a motivated and empowered community. The program developed and adapted the first educational resources in Spanish dedicated for young Mexican patients, as well as material for healthcare providers. As for research, a prospective cohort of young breast cancer patients was established to characterize clinicopathological features and psychosocial effects at baseline and during follow-up, as a guide for the development of specific cultural interventions addressing this vulnerable group. Eventually, it is intended that the program's organization and structure can reach national and international interactions and serve as a platform for other countries.