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.

Neoadjuvant carboplatin in triple-negative breast cancer: results from NACATRINE, a randomized phase II clinical trial.

BACKGROUND: Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of stages II and III triple-negative breast cancer (TNBC). This study aims to evaluate if the addition of carboplatin to NACT is associated with an increase in the pathological complete response (pCR) rates in TNBC. METHODS: We conducted an open-label phase II randomized clinical trial in a single center in Brazil. Patients with stage II and III TNBC were randomized to receive standard NACT with or without carboplatin. All the patients received doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) both intravenously (i.v.) q21 days for four cycles. Patients were then randomized for additional treatment with weekly (wk) paclitaxel (80 mg/m2 i.v., for 12 cycles) plus wk carboplatin AUC 1.5 (experimental arm) or without wk carboplatin (control arm). Randomization was stratified according to gBRCA status, age, and AJCC 8th edition clinical stage (II vs. III). The primary endpoint was the pathologic complete response (pCR) rate. Secondary endpoints included recurrence-free survival and overall survival. RESULTS: Between 2017 and 2021, 146 patients were randomized, 73 on each arm. The median age was 45 years. Most patients (66.4%) had locally advanced stage III disease, 67.1% had T3/T4 tumors, and 56.2% had clinically positive axillary lymph nodes. Germline BRCA status was available for all patients, and 19.9% had pathogenic BRCA1/2 variants. The pCR rate (ypT0ypN0) was numerically increased by 13.7%, being 43.8% (31 of 73 patients) in the experimental and 30.1% (22 of 73 patients) in the control arm, not meeting the prespecified goal of increasing the pCR in 15% (p-value = 0.08). Survival outcomes are immature. CONCLUSION: The addition of carboplatin to standard NACT in stages II and III TNBC was associated with a non-statistically significant numerical increase in the pCR rate. Follow-up for survival outcomes and translational research initiatives are ongoing.

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.

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.

Serum 25-hydroxyvitamin D and cancer-related fatigue: associations and effects on depression, anxiety, functional capacity and health-related quality of Life in breast cancer survivors during adjuvant endocrine therapy.

BACKGROUND: The adjuvant treatment with Aromatase Inhibitor (AI) is considered standard of care for postmenopausal breast cancer (BC) women with hormone receptor-positive (HR +), however, it often causes adverse effects such as cancer-related fatigue (CRF). The high prevalence of vitamin D deficiency in postmenopausal women who start adjuvant AI supports the hypothesis that hypovitaminosis D would be one of the biological explanations for toxicity of AI. This study aimed to identify the relationship between 25-hydroxyvitamin D [25(OH)D] and CRF, and to analyze their associations and effects on depression, anxiety, functional disability, muscle/joint aches and HRQL. METHODS: This prospective study included 89 postmenopausal women diagnosed with HR + early BC in adjuvant endocrine therapy with AI. Anthropometric and body composition assessments were performed, as well as dietary assessments by application of 24-h dietary recall, at three time points, totaling 24 months of follow-up. The women completed the Cervantes Scale (CS), Hospital Anxiety and Depression Scale (HADS) and Health Assessment Questionnaire (HAQ). The CRF was determined from the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F). The serum 25(OH)D was determined by electrochemiluminescence, with cut-off point above 75 nmol/L adopted as sufficiency. Generalized Linear Model (GLzM) and Generalized Mixed Model (GMM) analysis were used. RESULTS: At baseline, 36% (n = 32) of the women presented CRF and 39.3% (n = 35) had 25(OH)D below 75 nmol/L. None of the women reached the Estimated Average Requirements (EAR) of vitamin D. The causality between 25(OH)D and CRF was not significant. Longitudinally, lower levels of 25(OH)D had a negative effect on anxiety (p = 0.020), Menopause and Health (p = 0.033) and Vasomotor scores (p = 0.007). Also, the CRF had a negative effect on anxiety (p = 0.028); depression (p = 0.027); functional disability (p = 0.022); HRQL (p = 0.007); Menopause and Health (p = 0.042), Psychological (p = 0.008) and Couple Relations (p = 0.008) domains; and on Health (p = 0.019) and Aging (p = 0.036) subdomains. Vasomotor subdomain (ß = -2.279, p = 0.045) and muscle/joint aches (ß = -0.779, p = 0.013) were significant with CRF only at baseline. CONCLUSIONS: This study found negative effect of body adiposity on CRF. Still, the clinical relevance of 25(OH)D and CRF is highlighted, especially that of CRF, considering the consistent impact on several adverse effects reported by BC survivors during adjuvant endocrine therapy.

The Importance of Prognostication: Impact of Prognostic Predictions, Disclosures, Awareness, and Acceptance on Patient Outcomes.

OPINION STATEMENT: In the advanced cancer setting, patients, families, and clinicians are often confronted with an uncertain future regarding treatment outcomes and survival. Greater certainty on what to expect can enhance decision-making for many personal and healthcare issues. Although 70-90% of patients with advanced cancer desire open and honest prognostic disclosure, a small proportion do not want to know. Approximately half of patients with advanced cancer have an inaccurate understanding of their illness, which could negatively impact their decision-making. In this review, we use a conceptual framework to highlight 5 key steps along the prognostic continuum, including (1) prognostic formulation, (2) prognostic disclosure, (3) prognostic awareness, (4) prognostic acceptance, and (5) prognosis-based decision-making. We shall summarize the impact of prognostic predictions, disclosure, awareness, and acceptance on various patient and caregiver outcomes, such as hope, trust, anxiety, depression, chemotherapy use, and care planning. Based on where the patient is at along the prognostic continuum, we propose 5 different subgroups (avoidance: "I don't want to know"; discordant, "I never wanted to know"; anxious, "I don't know what's happening"; concerned, "I don't like this"; acceptance, "I know how to plan ahead"). Although prognostication is not necessarily a linear process, recognizing where the patient is at cognitively and emotionally along the prognostic continuum may allow clinicians to provide personalized interventions, such as specialist palliative care and psychology referral, towards personalizing prognostic disclosure, enhancing prognostic awareness, increasing prognostic acceptance, and supporting decision-making and, ultimately, improving patient outcomes.

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.

Late locoregional complications associated with adjuvant radiotherapy in the treatment of breast cancer: Systematic review and meta-analysis.

This systematic review with meta-analysis addressed late locoregional complications associated with adjuvant radiotherapy (RT) in breast cancer. Among 2120 titles, ten comparative studies in patients undergoing surgery vs surgery and radiotherapy reporting complications were evaluated. RT was associated with an increased risk of capsular contracture and decreased the mobility of the upper limb. A borderline association of lymphedema risk using RT was noted in the random-effects model but was significant in the fixed-effects model.

The impact of a higher eating frequency on the diet quality and nutritional status of women with breast cancer undergoing chemotherapy.

The present study investigated the association between eating frequency (EF), diet quality and nutritional status of fifty-five women with breast cancer (BC) undergoing chemotherapy (CT), with three follow-ups, before the first cycle (T0), after the intermediate cycle (T1) and after the last cycle of CT (T2). Dietary data were obtained by nine 24-h dietary recalls (24HR), and the Brazilian Healthy Eating Index Revised (BHEI-R) was used for qualitative analysis of diet. The average EF was established by adding the number of daily eating episodes in the three 24HR of each time. Anthropometric variables were obtained at three times. Women who reported higher EF (equal to or above median value (T0 and T1: 4·67; T2: 4·33 eating episodes)) presented better anthropometric parameters, in T0 and T1, as well as higher scores for BHEI-R specific groups and BHEI-R Total score in T1 and T2. In generalised linear models, the continuous variable EF was negatively associated with all the anthropometric variables in T0 and with the waist:height ratio in T1. There were positive associations for the BHEI-R groups at the three times: Total Fruit; Whole Fruit; Total Vegetables; Dark Green and Orange Vegetables and Legumes. At T1 and T2 the EF was positively associated with the BHEI-R Total score, and also with Whole Grains in T1. The results suggest that a higher EF was associated with a better diet quality during CT in women with BC. In contrast, an inverse association was observed between EF and anthropometric parameters before the first cycle of treatment.

Health-related quality of life became worse in short-term during treatment in head and neck cancer patients: a prospective study.

BACKGROUND: Quality of life (QoL) is influenced in head and neck cancer (HNC) patients by a set of factors related to diagnosis, treatment and tumor impacts. The aim of this study was to evaluate the Quality of Life (QoL) changes in Head and Neck cancer (HNC) patients during treatment (radiotherapy and/or chemoradiotherapy). METHODS: QoL was evaluated prospectively in 63 HNC patients during radiotherapy and/or chemoradiotherapy at three moments: before or at beginning (T0), in the middle (T1 ~ four weeks) and immediately at the end (T2 ~ eight weeks) of treatment. The differences between the scores at different time points was verified using Friedman's non-parametric test. Negative changes between time points were evaluated, with differences (delta) of ±10 points being considered to be clinically significant. RESULTS: The total mean age was 59.1 ± 9.5y, and 82.5% were male. The oral cavity and larynx were more frequent tumors. The functional score for 'role' was decreased at time points T1 and T2 as compared to T0, while an improvement in scores was observed for cognitive function. Several physical symptoms also worsened over time, such as: fatigue, nausea and vomiting, dry mouth and sticky saliva, swallowing and skin symptoms, senses and teeth problems. A high frequency of altered and clinically meaningful values were observed for most of domains, ranging from 6 to 74%. CONCLUSIONS: The QoL became worse at approximately one month after treatment beginning in HNC patients, and this remained until the end of therapy. Protocols directing to early nutritional counseling and management of symptoms of nutritional impact are important to improve clinical outcomes. This is part of preventive actions aiming to make the exhausting treatment process less traumatic and easier to complete.

Factors associated with return to work in breast cancer survivors treated at the Public Cancer Hospital in Brazil.

PURPOSE: To evaluate the impact of return to work on the quality of life of breast cancer patients and to identify factors related to nonreturn to work. METHODS: An observational, cross-sectional study was performed in breast cancer survivors who had worked before their breast cancer diagnosis. We evaluated factors related to return to work (patient perspective, disease, and work), EORTC quality of life questionnaires (general: EORTC QLQ-C30; and breast cancer-specific: EORTC QLQ-BR23), the Shoulder Pain and Disability Index (SPADI), and the Anxiety and Depression Scale (HADS). Half of the patients underwent a physical therapy examination (shoulder goniometry, hand dynamometry, and limb volume). Univariate and multivariate analysis were performed. RESULTS: We included 304 patients, 163 of whom underwent physiotherapy evaluation. Approximately 54.0% (164) of the patients returned to work after treatment. The women who returned to work presented lower age, higher education levels, higher incomes, and smaller initial tumor size. The women who returned to work had higher scores related to body image and sexual function, lower scores in relation to disability and pain, and lower scores related to anxiety and depression. In the multivariate model to evaluate nonreturn to work, pretreatment variables were age, education level, and clinical staging. Sequelae related to loss of strength increased the risk of nonreturn to work. CONCLUSION: Return to work was influenced by age, education level, previous activity types, axillary treatment, and physical sequelae related to loss of hand strength. Breast cancer treatment decreased the women's work capacity. Return to work improved the patients' quality of life.

Meaning in life in patients with advanced cancer: a multinational study.

BACKGROUND: Few studies have examined meaning in life, a novel existential outcome, in patients with advanced cancer across countries. OBJECTIVES: We examined differences in meaning in life across 5 countries and identified factors associated with meaning in life. METHODS: This is a pre-planned secondary analysis of a prospective longitudinal multicenter observational study of patients with advanced cancer. Meaning in life was assessed using a validated scale which examined four domains of meaning: values, purpose, goals, and reflection. The total score ranged from 8 to 32, with a higher score indicating greater meaning in life. RESULTS: Among 728 patients, the median meaning in life score was 25/32 (interquartile range 23, 28). There was no significant difference in the total meaning in life score among 5 countries (P = 0.11), though there were differences in domain sub-scores. In the univariate analysis, patients with higher intensity of physical symptoms by ESAS score (pain, fatigue, drowsiness, dyspnea, insomnia), depression, anxiety, spiritual pain, and financial distress had significantly lower meaning in life. However, patients with higher levels of education, who were married, and who had higher optimism had significantly higher meaning in life. In the multivariate analysis, higher total meaning in life scores were significantly associated with greater optimism (multivariate estimate = 0.33, p < 0.001), lower depression (- 0.26, < 0.001), spiritual pain (- 0.19, < 0.001), and financial distress (- 0.16, < 0.001). CONCLUSION: Country of origin was not a determinant of meaning in life. However, meaning in life was significantly associated with optimism, depression, spiritual pain, and financial distress, underscoring the multidimensional nature of this construct and potential opportunities for improvement in addressing meaning in life of patients with advanced cancer.

Predicting survival in patients with advanced cancer in the last weeks of life: How accurate are prognostic models compared to clinicians' estimates?

BACKGROUND: It is unclear if validated prognostic scores such as the Palliative Performance Scale, Palliative Prognostic Index, and Palliative Prognostic Score are more accurate than clinician prediction of survival in patients admitted to an acute palliative care unit with only days of survival. AIM: We compared the prognostic accuracy of Palliative Performance Scale, Palliative Prognostic Index, Palliative Prognostic Score, and clinician prediction of survival in this setting. DESIGN: This is a pre-planned secondary analysis of a prospective study. SETTING/PARTICIPANTS: We assessed Palliative Performance Scale, Palliative Prognostic Index, Palliative Prognostic Score, and clinician prediction of survival at baseline. We computed their prognostic accuracy using the Concordance index and area under the receiver operating characteristics curve for 7-, 14-, and 30-day survival. RESULTS: A total of 204 patients were included with a median overall survival of 10 days (95% confidence interval: 8-11 days). The Concordance index for Palliative Performance Scale, Palliative Prognostic Index, Palliative Prognostic Score, and clinician prediction of survival were 0.74, 0.71, 0.70, and 0.75, respectively. The areas under the curve for these approaches were 0.82-0.87 for 30-day survival, 0.75-0.80 for 14-day survival, and 0.74-0.81 for 7-day survival. The four prognostic approaches had similar accuracies, with the exception of 7-day survival in which clinician prediction of survival was significantly more accurate than Palliative Prognostic Score (difference: 7%) and Palliative Prognostic Index (difference: 8%). CONCLUSION: In patients with advanced cancer with days of survival, clinician prediction of survival and Palliative Performance Scale alone were as accurate as Palliative Prognostic Score and Palliative Prognostic Index. These four approaches may be useful for prognostication in acute palliative care units. Our findings highlight how patient population may impact the accuracy of prognostic scores.

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.

Prognostication in advanced cancer: update and directions for future research.

The objective of this review is to provide an update on prognostication in patients with advanced cancer and to discuss future directions for research in this field. Accurate prognostication of survival for patients with advanced cancer is vital, as patient life expectancy informs many important personal and clinical decisions. The most common prognostic approach is clinician prediction of survival (CPS) using temporal, surprise, or probabilistic questions. The surprise and probabilistic questions may be more accurate than the temporal approach, partly by limiting the time frame of prediction. Prognostic models such as the Glasgow Prognostic Score (GPS), Palliative Performance Scale (PPS), Palliative Prognostic Score (PaP), Palliative Prognostic Index (PPI), or Prognosis in Palliative Care Study (PiPS) predictor model may augment CPS. However, care must be taken to select the appropriate tool since prognostic accuracy varies by patient population, setting, and time frame of prediction. In addition to life expectancy, patients and caregivers often desire that expected treatment outcomes and bodily changes be communicated to them in a sensible manner at an appropriate time. We propose the following 10 major themes for future prognostication research: (1) enhancing prognostic accuracy, (2) improving reliability and reproducibility of prognosis, (3) identifying the appropriate prognostic tool for a given setting, (4) predicting the risks and benefits of cancer therapies, (5) predicting survival for pediatric populations, (6) translating prognostic knowledge into practice, (7) understanding the impact of prognostic uncertainty, (8) communicating prognosis, (9) clarifying outcomes associated with delivery of prognostic information, and (10) standardizing prognostic terminology.