A Research Protocol for a Phase II Single-Arm Clinical Trial Assessing the Feasibility and Efficacy of Neoadjuvant Anastrozole in Patients With Luminal Breast Cancer and Low Proliferative Index: The ANNE Trial.

INTRODUCTION: Neoadjuvant endocrine therapy (NET) is recommended for the treatment of invasive breast cancer (BC), particularly luminal subtypes, in locally advanced stages. Previous randomized studies have demonstrated the benefits of aromatase inhibitors in this context. However, NET is typically reserved for elderly or frail patients who may not tolerate neoadjuvant chemotherapy. Identifying non-responsive patients early and extending treatment for responsive ones would be ideal, yet optimal strategies are awaited. AIMS: This non-randomized phase 2 clinical trial aims to assess NET feasibility and efficacy in postmenopausal stage II and III luminal BC patients, identifying predictive therapeutic response biomarkers. Efficacy will be gauged by patients with Ki67 ≤ 10% after 4 weeks and Preoperative Endocrine Prognostic Index (PEPI) scores 0 post-surgery. Study feasibility will be determined by participation acceptance rate (recruitment rate ≥50%) and inclusion rate (>2 patients/month). METHODS: Postmenopausal women with luminal, HER2-tumors in stages II and III undergo neoadjuvant anastrozole treatment, evaluating continuing NET or receiving chemotherapy through early Ki67 analysis after 2 to 4 weeks. The study assesses NET extension for up to 10 months, using serial follow-ups with standardized breast ultrasound and clinical criteria-based NET suspension. Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.

When and how to discuss about palliative care and advance care planning with cancer patients: A mixed-methods study.

OBJECTIVES: To identify the patients who are most likely to participate in discussions about palliative care (PC) and advance care planning (ACP), and to determine their preferred timing and approach of discussion. METHODS: The study included women aged 18-75 years diagnosed with breast cancer. In the quantitative phase, sociodemographic and clinical characteristics, knowledge, decision-making, and stigmas were evaluated. The qualitative phase included questions about patients' understanding, timing, and method of discussing PC and ACP, which were analyzed by Bardin's content analysis. RESULTS: In Phase 1, a total of 115 participants were included, with 53.04% completing both phases and 46.96% declining further participation. Those who completed both phases exhibited higher rates of marriage and educational attainment, while those who declined Phase 2 had a higher prevalence of advanced-stage cancer and palliative treatment. Completion of both phases was associated with a greater knowledge of reality and increased awareness of PC and ACP. Furthermore, the qualitative analysis revealed 5 convergent themes: timing, demystification, patient empowerment, misconception elimination, and open communication. These themes informed the development of a conceptual model that provides a framework for discussing PC and ACP with patients at different stages of cancer diagnosis and treatment, highlighting appropriate and inappropriate approaches and timing. SIGNIFICANCE OF RESULTS: Early discussion is beneficial, but withholding information or infringing on autonomy should be avoided. The study reveals that married and highly educated individuals tend to be more receptive to these discussions. However, patients with late-stage cancer tend to decline participation. Patients value open communication, demystification of PC, and empowering discussions that eliminate misunderstandings. Efforts should be made to reach patients with limited familiarity, particularly those with late-stage cancer, to increase their receptiveness to enable well-informed decision-making.

Translation and cross-cultural adaptation of the Posthumous Dignity Therapy Schedule of Questions to Brazilian Portuguese.

OBJECTIVES: Dignity Therapy (DT) is a brief form of psychotherapy that helps people with life-threatening illnesses and their loved ones cope with emotional pain and demoralization. Unfortunately, not everyone has the opportunity to receive DT during their lifetime. Posthumous Dignity Therapy (PDT) was then devised to be administered to bereaved family members. However, PDT has not yet been validated or studied in the specific cultural and linguistic context of Portuguese-Brazilians. This study aims to fill this gap by validating PDT for the Portuguese (Brazilian) context. METHODS: Using Beaton's methodology, including the processes of translation, synthesis, back-translation, evaluation by an expert committee, and pre-testing, the PDT Schedule of Questions underwent validation and cultural adaptation. The research was conducted in a Palliative Care Unit at a tertiary cancer hospital in Brazil. RESULTS: The questionnaire was translated, back-translated, and evaluated by the panel of experts, obtaining a Content Validity Index of 0.97. During the pretest phase, it was observed that the participant's interview method needed to be changed from remote (telephone or videoconference) to in-person. Additionally, it was necessary to modify some terms related to death and dying, as they caused discomfort to the participants. As a result of this process, the PDT was modified, and adapted to the Brazilian cultural and linguistic reality. SIGNIFICANCE OF RESULTS: This validation study will be significant for future DT research from the caregivers' perspective and for projects aiming to implement this therapeutic modality in palliative care units, in addition to helping participants remember their loved ones better by providing a tangible legacy document that assists them emotionally and materially in coping with the grieving process.

To Treat or Not to Treat? Dilemmas when Deciding on Antineoplastic Treatment in Patients With Far Advanced Cancers.

Patients with advanced cancers and their oncologists are often faced with difficult treatment decisions, especially when there are borderline situations of expected benefit or increased risk of complications. In this narrative review, we will explore the decision-making process for patients with advanced cancers and provide insights on how to approach this complex task, while didactically dividing the oncologist's assessments according to a mnemonic rule of the ABCDE of therapeutic decision-making. Part A (advanced cancer) recalls that the rule is to be used specifically for advanced cancers. Parts B (potential benefits) and C (clinical conditions and risks) represents the traditional risk vs benefit scale. In Part D, we discuss ways to identify and understand patients' desires, values, preferences, and beliefs. The prognostic estimation, from Part E, may function as an "adjust" for the antineoplastic treatment decision-making. Treatment decisions need to be conducted by skilled oncologists, in a patient-centered care, aiming to promote valuable oncology with lower rates of aggressive care.

Personalizing the Setting of Palliative Care Delivery for Patients with Advanced Cancer: "Care Anywhere, Anytime".

OPINION STATEMENT: The specialty of palliative care has evolved over time to provide symptom management, psychosocial support, and care planning for patients with cancer throughout the disease continuum and in multiple care settings. This review examines the delivery and impact of palliative care in the outpatient, inpatient, and community-based settings. The article will discuss how these 3 palliative care settings can work together to optimize patient outcomes under a unifying model of palliative care "anywhere, anytime" and how to prioritize palliative care services when resources are limited. Many patients with advanced cancer receive care from each of the 3 branches of palliative care-outpatient, inpatient, and community-based settings-at some point along their disease trajectory. Early on, outpatient clinics provide longitudinal supportive care concurrent with active disease-modifying treatments. Telemedicine appointments can serve patients remotely to minimize their need to travel. When patients experience functional decline, community-based palliative care services can provide support and monitoring for patients at home. When patients develop acute symptomatic complications requiring admission, inpatient care consultation teams are essential for symptom management and goals-of-care discussions. For patients in severe distress, receiving care in a palliative care unit that provides intensive symptom control and facilitates complex discharge planning is ideal. Under a unifying model of palliative care designed to offer care "anywhere, anytime," the 3 branches of palliative care could work in unison to support each other, minimize gaps in care, and optimize patient outcomes.

"Mãos de Conforto" (Hands of Comfort): A novel non-pharmacological intervention to ease agitation in elderly persons with dementia.

Behavioral symptoms associated with dementia, such as agitation, are frequent and associated with well-known negative consequences for patients, their carers, and their environment. Pharmacological treatments for agitation using sedatives and antipsychotics are known to have several undesirable side effects and modest efficacy. Non-pharmacological alternatives are recommended as first-line options for agitation in persons with dementia with few side effects, but there is limited evidence of efficacy. We developed a novel and simple non-pharmacological alternative for agitation in dementia residents based on a Brazilian intervention using warm water surgical gloves used in patients with COVID-19 in intensive care units during the pandemic. We coined it "Mãos de Conforto" - Hands of Comfort. We report a series of 7 cases in 3 residents with dementia who whore Hands of Comfort.

Translation and cross-cultural adaptation of the Dignity Therapy Question Protocol to Brazilian Portuguese.

OBJECTIVES: Dignity therapy (DT) was developed to help patients at their end of life to reframe and give meaning to their illness process. The DT question protocol focuses on personhood and important aspects of the individual's life. This study aimed to translate and culturally adapt the Dignity Therapy Question Protocol (DTQP) to Brazilian Portuguese. METHODS: This was a descriptive and methodological study, and cross-cultural adaptation process comprised 4 stages: (1) translation and synthesis of English original version protocol into Brazilian Portuguese, (2) back translation, (3) experts committee, and (4) pretest. RESULTS: The Portuguese version of the DTQP - Protocolo de Perguntas sobre Terapia da Dignidade - demonstrated a content validity index of 1 for all equivalences. The initial sample consisted of 41 participants (9 [21.9%] refused to participate and 1 [2.43%] dropped out). The pretest was applied to 30 (73.1%) participants, 15 of them were female and the mean age was 53.4 years. The final version consisted of 10 questions that were approved by the original authors who affirmed that the DTQP Brazilian Portuguese version maintained the original English characteristics. SIGNIFICANCE OF RESULTS: The Brazilian cultural adaptation of the DTQP was well understood by patients. It will be very useful in palliative care clinical practice for patients nearing end of life. The adapted version to Brazilian Portuguese will facilitate future studies using the DTQP.

Influence of advance directives on reducing aggressive measures during end-of-life cancer care: A systematic review.

CONTEXT: Although the literature recognizes the participation of patients in medical decisions as an important indicator of quality, there is a lack of consensus regarding the influence of advance directives (ADs) on reducing aggressive measures during end-of-life care involving cancer patients. OBJECTIVE: A systematic review was conducted to analyze the influence of ADs on reducing aggressive end-of-life care measures for cancer patients. METHOD: We searched the Medline, Embase, Web of Science, and Lilacs databases for studies published until March 2018 using the following keywords, without language restrictions: "advance directives," "living wills," "terminal care," "palliative care," "hospice care," and "neoplasms." Article quality was assessed using study quality assessment tools from the Department of Health and Human Services (NHLBI). RESULTS: A total of 1,489 studies were identified; 7 met the inclusion criteria. The studies were recently published (after 2014, 71.4%). Patients with ADs were more likely to die at the site of choice (n = 3) and received less chemotherapy in the last 30 days (n = 1). ADs had no impact on intensive care unit admission (n = 1) or hospitalization (n = 1). One study found an association between ADs and referral to palliative care, but other did not find the same result. SIGNIFICANCE OF RESULTS: Of the seven articles found, four demonstrated effects of ADs on the reduction in aggressive measures at the end of life of cancer patients. Heterogeneity regarding study design and results and poor methodological quality are challenges when drawing conclusions.

Development of a screening tool to improve the referral of patients with breast and gynecological cancer to outpatient palliative care.

OBJECTIVE: New strategies that allow timely referral to outpatient palliative care (PC) for cancer patients are sought. The authors developed a 16-item checklist tool with 3 categories of care priorities based on patients' physical functionality. To evaluate the potential clinical impact of the use of these criteria in patients with advanced breast and gynecological cancer (ABGC) seen at oncology clinics. METHODS: The study was divided into 2 phases. In Phase I, research nurse prospectively assessed the referral criteria among patients with ABGC who had not yet been referred to PC. The oncologists' (routine) referral rate was compared to the referral rate if the criteria were applied universally. In Phase II, we implemented routine screening with these referral criteria without automatic trigger. Patients not yet evaluated by PC were retrospectively evaluated regarding the rate of screening and how often they met criteria. RESULTS: Among the 120 patients evaluated in Phase I, oncologists referred 23 (19%) and the screening criteria identified another 82 (68%) who may benefit from PC, potentially increasing the PC referral rate by 3.2-fold. Patients would have been referred earlier using the criteria than based on oncologists' judgement (median survival 451 days vs. 178, p < 0.001). In Phase II, among the patients who were not yet receiving PC, 38.6% (97 of 251) met at least one criterion. CONCLUSION: The use of referral criteria has the potential to significantly increase the number of timely palliative care referral. Further research is needed to test the implementation of these criteria.

An explorative analysis of the differences in levels of happiness between cancer patients, informal caregivers and the general population.

BACKGROUND: Although cancer patients experience distressing symptoms and health-related changes in their quality of life, they may report positive emotional states. The lives of informal caregivers of cancer patients may also be affected by the patient's cancer diagnosis; however, they may also find benefits in their experiences. Noticeable changes are reported in personal priorities after an oncologic diagnosis that can lead individuals to restructure their values and the way they perceive life. This study aims to assess happiness/satisfaction with life and positive and negative affect in cancer patients and informal caregivers compared with healthy people in the general population. METHODS: A cross-sectional study with participants recruited online in five regions of Brazil through the social network site Facebook® and the application WhatsApp®. Surveys were completed using the SurveyMonkey® platform. A different sample of cancer patients and informal caregivers that was personally interviewed with the same forms was also grouped in the present analysis. Variables with p-values < 0.05 in the univariate analysis were included in linear regression models (stepwise, backward). RESULTS: A total of 2580 participants were included, of whom 2112 were healthy representatives of the general population, 342 were cancer patients, and 126 were informal caregivers of cancer patients. In the multivariate analysis, the cancer patients and informal caregivers were happier than the healthy people in the general population, even after controlling for age, sex, educational level, and income. The patients and caregivers had lower scores for positive affect and higher scores for negative affect. CONCLUSIONS: Overall, the conditions related to happiness, satisfaction with life and positive affect are similar for all groups. However, cancer patients and informal caregivers report increased rates of happiness and satisfaction with life compared with theoretically healthy people, although they have lower positive affect scores and higher negative affect scores. It is suggested that cancer patients and caregivers of cancer patients experience more difficulties (suffering) on ​​a daily basis. However, given the increased difficulties, they perceive life differently, reporting that they are happier.

Validation of the Brazilian version of the Shame and Stigma Scale (SSS-Br) for patients with head and neck cancers.

OBJECTIVE: To evaluate the psychometric properties of the Brazilian version of the Shame and Stigma Scale (SSS) in a sample of patients with head and neck cancers (HNC). METHODS: This is a validation study carried out in a Brazilian cancer hospital. Patients over 18 years old who knew about their HNC diagnosis were consecutively recruited, answering the SSS, the Functional Assessment of Cancer Therapy (General and Head and Neck supplement) questionnaire, and the University of Washington Quality of Life Questionnaire. Internal consistency, test-retest procedure, convergent validity, and responsiveness analysis were the psychometric properties evaluated. RESULTS: A total of 122 HNC patients were included. The SSS showed appropriate internal consistency (alphas ranging from 0.71 to 0.86), test-retest reliability (higher than 0.92 with exception of the "Regret domain"), and convergent validity. The responsiveness analysis with 38 patients was able to discriminate the scores before and after prosthetic procedures. SIGNIFICANCE OF THE RESULTS: The Brazilian Portuguese version of the SSS may be considered a valid and reliable instrument for the evaluation of Brazilian patients with HNC. Future SSS validation studies are welcome in other developing countries in order to make cancer health providers aware of these negative feelings in their HNC patients.

Impact of AferBio® on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial.

BACKGROUND: Lung cancer patients undergoing palliative chemotherapy exhibit many symptoms related to the disease, such as adverse events and infectious complications during treatment, which impacts directly their health-related quality of life (HRQOL). Nutritional status is a relevant aspect among advanced cancer patients under palliative care and food supplementation has the potential to reduce treatment-related adverse effects and improve the nutritional status. The product named AferBio® is a fermented supplement that has been described as able to provide some benefits, including the capacity to potentiate the effects of anticancer drugs, by promoting the reduction of side effects and ultimately improving HRQOL. METHODS/DESIGN: A Phase II double-blind placebo-controlled randomized clinical trial to assess the use of food supplementation with AferBio® in Stage IIIB or IV non-small cell lung cancer (NSCLC) patients beginning a second-line palliative mono-chemotherapy. The primary goal is to compare HRQOL scores between the arms of the study over time. The ten first patients included in the present study will undergo an AferBio®toxicity-testing (non-randomized phase). If no significant toxicity is found, the study will move on to the randomized phase. All patients will be randomized in blocks at a 1:1 ratio using the online tool REDCap. ECOG-PS (0-1 versus 2) criteria will be used for stratification. All patients included in the trial will be evaluated at baseline and at each chemotherapy cycle. Each evaluation will include the following: HRQOL (EORTC QLQ-C30, LC13 and IQualiV-Lung), ECOG-PS, anthropometric measurements, clinical and laboratory toxicity assessment and response evaluation. DISCUSSION: During palliative systemic therapy in advanced cancer patients, one of the main goals is the improvement and maintenance of HRQOL, which can be negatively affected by cancer symptoms, cancer- or treatment-related psychosocial difficulties, and chemotherapy toxicity. Thus, much research has been dedicated to the development of new and more effective and/or less toxic cancer therapies. The present study is justified by the testing of a novel food supplement that may reduce some toxicities, thus, having a potential positive impact on the HRQOL of lung cancer patients. The product in question (AferBio®) is already available for sale in Brazil, but has not yet been fully tested in cancer patients. TRIAL REGISTRATION: This Trial was registered on March 19, 2018 with ClinicalTrials.gov , NCT03469063. Protocol version: 2.0 from March 26, 2018. Trial status: Patient enrollment in the study began in April, 2018.

Doctor, are you healthy? A cross-sectional investigation of oncologist burnout, depression, and anxiety and an investigation of their associated factors.

PURPOSE: Doctors who work at cancer hospitals are at high risk of developing emotional distress. This study evaluated the prevalence of burnout, anxiety, and depression in a sample of oncologists of various specialties and sought to identify how much of this distress is explained by specific pre-established characteristics. METHODS: This cross-sectional study used online surveys. Burnout was measured using the Maslach Burnout Inventory (MBI), and anxiety and depression were measured using the Hospital Anxiety and Depression Scale (HADS). The variables associated with p-values < 0.10 in the univariate analyses were included in blocks of hierarchical binary logistic regression models to identify the predictors of burnout, depression, and anxiety. RESULTS: Of the 227 physicians (response rate = 70.5%), 132 (58.1%) were identified as having burnout (high emotional exhaustion [EE] and depersonalization [DP]); furthermore, 28 (12.3%) had depression (HADS-D ≥ 11), and 44 (19.4%) had anxiety (HADS-A ≥ 11). The block of perceptions related to the workplace explained 22.4%, 7.7%, and 10.6% of the variances of burnout, depression, and anxiety, respectively. On the other hand, the outside-of-work characteristics block explained only 3.1%, 13.4%, and 3.4% of the variances of burnout, depression, and anxiety, respectively. CONCLUSIONS: Work-related stressors are associated with burnout, but few are associated with anxiety and depression. Outside-of-work characteristics explained little of the distress reported by physicians. Strategies focused on perceptions of professional recognition and lower workloads that stimulate positive relationships between doctors and other health professionals are desirable in oncological context.

Factors associated with palliative care referral among patients with advanced cancers: a retrospective analysis of a large Brazilian cohort.

PURPOSE: The purpose of the study is to estimate the proportion of patients who had access to palliative care (PC) and to identify the timing and factors associated with this access. METHODS: A retrospective longitudinal study that included patients who died of advanced cancer between the years of 2010 and 2014 was conducted. The proportion of patients who received PC consultations was compared during those years. Sociodemographic and clinical factors, the timing between first PC consultation and death (early, ≥ 3 months; late, < 3 months), and first PC consultation were assessed. RESULTS: Of the 1284 studied patients, 988 (76.9%) were referred to PC and 839 (65.3%) had a PC consultation. The proportion of patients who received late PC consultation increased between the years 2010 and 2014 (44.2 vs. 60.4%, p = 0.001). Multivariate analysis revealed that younger age (odds ratio (OR) = 0.98, p = 0.016) and gynecologic cancer (OR = 2.17, p = 0.011) were associated with a PC consultation. Upper gastrointestinal tract (GIT) cancer (OR = 2.42, p = 0.001) and hematologic malignancies (OR = 0.37, p = 0.001) were associated with late PC consultations. The median time interval between the first PC consultation and death was 2.66 months: timing differed significantly among cancer subtypes (p = 0.002). CONCLUSION: Most patients received PC consultation before death, and the number of patients with late consultation increased throughout the study. Patients with late referrals could have received PC earlier. The current findings suggest the need to standardize the referral criteria to optimize access to PC.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

BACKGROUND: The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. METHODS: An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. RESULTS: From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). CONCLUSIONS: Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. TRIAL REGISTRATION: Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

End-of-life experiences and deathbed phenomena as reported by Brazilian healthcare professionals in different healthcare settings.

OBJECTIVE: The objectives of the present study were to describe and compare the characteristics and reports of end-of-life experiences (ELEs) by healthcare professionals at different institutions and to investigate the influence of religious beliefs on these reports. METHOD: A multicenter study was carried out in Brazil that included six nursing homes (NHs), a cancer hospital (ONC), and a palliative care (PC) unit. Sociodemographic data, ELE reports (Fenwick's questionnaire), religiosity (the Duke Religion Index), spirituality (the Spirituality Self-Rating Scale), and mental health (the DASS-21 questionnaire) were assessed. The analysis was performed using ANOVA and chi-square tests in order to compare ELE perceptions in these different settings. RESULTS: A total of 133 healthcare professionals (46 ONC, 36 PC, and 51 NH) were interviewed, 70% of whom recounted at least one ELE report in the previous five years. The most common ELEs were "visions of dead relatives collecting the dying person" (88.2%), "a desire to mend family rifts" (84.9%), and "visions of dead relatives near the bed providing emotional comfort" (80.6%). Most healthcare professionals (70-80%) believed that these experiences had a spiritual significance and were not due to biological effects. Comparison among settings revealed that those working in the PC unit had more reports, a greater openness about the issue, and more interest in training. Individual religious beliefs had no influence on perception of ELEs. SIGNIFICANCE OF RESULTS: Our study revealed that ELE reports are not uncommon in clinical practice and seem to be little influenced by religious or spiritual beliefs. Although strongly reported in all settings, palliative care professionals tend to be more open to this issue and have a stronger perception of ELEs.

Associations of Body Mass Index and Physical Activity With Sexual Dysfunction in Breast Cancer Survivors.

Sexual dysfunction is a common and distressing consequence of breast cancer (BC) treatment. In the present study, we investigated the sexual functioning of BC patients and its association with women's personal characteristics and cancer treatments. In this cross-sectional study, sexual function was assessed using the Female Sexual Function Index (FSFI). The health-related quality of life (HRQOL) was measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and its breast module BR-23. Of the 235 participants approached, 216 participants were included in the study. Of these, 63 patients reported no sexual activity in the last month and thus were analyzed only in relation to the sexual desire domain of FSFI. A total of 154 (71.3 %) patients were classified with hypoactive sexual desire disorder (HSDD). From those patients reporting sexual activity in the last month, 63.3 % (97 out of 153) were classified with sexual dysfunction. Using hierarchical logistic regression, the variance explained (change in R 2) by the addition of body mass index (BMI) and mild to moderate physical activity in the prediction models of sexual dysfunction and HSDD were 6.8 and 7.2 %, respectively. Age, BMI, and physical activity were independently associated with sexual dysfunction and HSDD. Additionally, BC patients with sexual dysfunction reported lower scores on global HRQOL, role functioning, and fatigue. Based on our findings, BC survivors should be encouraged to practice regular physical activity and to lose weight in order to avoid sexual dysfunction. However, future clinical trials are needed to confirm these findings.

The Functionality Assessment Flowchart (FAF): a new simple and reliable method to measure performance status with a high percentage of agreement between observers.

BACKGROUND: Performance status (PS) assessment is an integral part of the decision-making process in cancer care. Karnofsky Performance Status (KPS) and Eastern Cooperative Oncology Group (ECOG) PS are the most widely used tools. In some studies, the absolute agreement rate of these tools between observers has been moderate to low. The present study aimed to evaluate the inter-observer reliability and construct validity of the new Functionality Assessment Flowchart (FAF) and compare it with ECOG PS and KPS in a sample of cancer patients. METHODS: The patients were recruited by convenience from the waiting rooms of the Breast and Gynecology Ambulatory in a cross-sectional study. Two trained medical students (observer A) and five medical oncologists (observers B) independently rated women according to the ECOG PS, KPS and FAF. After the determining the PS scores, observer A administered the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire to the participants. The agreements between observers A and B were investigated using the absolute agreement rate (%), weighted and unweighted kappa and Spearman's correlation test. For construct validity, the PS scores were correlated with functional and fatigue scores by performing correlation analysis. RESULTS: Eighty women with a median age of 57 years were included in the study (86% accrual rate). Among these women, 39 (48.8%) had advanced cancer. The overall absolute agreement rate between observers was 49.4% for KPS, 67% for ECOG PS, and 78.2% for FAF. When using unweighted kappa values, the inter-observer reliability was "fair", "moderate" and "substantial" for KPS, ECOG PS and FAF, respectively. However, when using weighted kappa statistics, "substantial" agreement was observed for KPS and ECOG PS and "nearly perfect" agreement was observed for FAF. All of the PS scales correlated very well with the functional and fatigue scores. CONCLUSIONS: We present a new instrument with moderate to high inter-observer agreement and adequate construct validity to measure PS in cancer patients.

Validation of the Holistic Comfort Questionnaire-caregiver in Portuguese-Brazil in a cohort of informal caregivers of palliative care cancer patients.

PURPOSE: The aims of this study were to perform a cross-cultural adaptation and to assess the psychometric properties of the Portuguese (Brazil) version of the Holistic Comfort Questionnaire-caregiver (HCQ-caregiver) in a sample of family caregivers (FCs) of palliative care (PC) cancer patients. METHODS: The HCQ-caregiver was applied by a trained interviewer to a sample of 150 FCs of PC patients with advanced cancer; 50 participants were subjected to a retest 2 to 7 days after the initial test. The mean score, ceiling and floor effects, and skewness of each HCQ-caregiver item were measured. The instrument's internal consistency was assessed by means of Cronbach's alpha, and the test-retest reliability was assessed using the intraclass correlation coefficient (ICC). The convergent validity was assessed through the correlation between HCQ-caregiver and quality of life scores. Scores on the HCQ-caregiver were compared (discriminant validity) as a function of treatment setting and FC's self-perception of emotional health. RESULTS: A ceiling effect was found in 19 items, four of which exhibited maximum response rates above 90 % and inadequate results regarding skewness. Cronbach's alpha was 0.858, and the ICC was 0.961. The scores on the HCQ-caregiver exhibited moderate-to-strong correlations with the scores of quality of life. The FCs' perceptions of comfort did not differ as a function of the treatment setting but were greater when the FCs had a better self-perception of their emotional health. CONCLUSIONS: The present study demonstrates the validity and reliability of the Brazilian version of the HCQ-caregiver.