Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study.

Patients' self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients. Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients' reporting of side-effects. We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors. The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions. Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires. In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer. The study is registered on clinicaltrials.gov (NCT04416672).

How early should be "Early Integrated Palliative Care"?

Palliative care, with its focus on comprehensive patient assessment encompassing physical, social, emotional, and spiritual pain, plays a crucial role in modern medicine. Despite its significance, integration with oncology and other healthcare specialties often occurs late in the disease trajectory. Strategies to bridge this gap include considering a "rebranding" of palliative care to "supportive care." Early initiation of palliative care, although challenging to define precisely, aims to improve the quality of life for patients and their families. Studies show some benefits, but the evidence remains limited. An embedded model that encourages interdisciplinary collaboration between oncologists and palliative care practitioners has shown promise. However, it raises questions about training and availability of palliative care specialists. A broader approach involves integrating palliative care principles into medical and nursing education to ensure early recognition of patient needs and empathetic communication. Regular monitoring of patients' physical and non-physical needs, along with appropriate interventions, can alleviate suffering and improve patient outcomes. Ultimately, the integration of palliative care into oncology and other disciplines focuses on addressing the individual's needs and understanding their unique experience of suffering.

Pre-treatment risk factors to predict early cisplatin-related nephrotoxicity in locally advanced head and neck cancer patients treated with chemoradiation: A single Institution experience.

OBJECTIVES: Cisplatin is essential in the curative treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. The assessment of risk factors to predict an early cisplatin-induced nephrotoxicity could help in better managing one of the most relevant cisplatin-related dose-limiting factors. MATERIAL AND METHODS: We retrospectively collected data of LA-HNSCC patients treated at our Institution from 2008 to 2019. Patients received cisplatin in a curative setting concurrently with radiation. Acute Kidney Injury (AKI) was assessed as a dichotomous variable (CreaIncr) based on pre-treatment values, and values recorded at days 6-20 post-first cycle of cisplatin. Univariable logistic regression models were performed to investigate associations between CreaIncr and clinical characteristics. A multivariable logistic model on a priori selected putative covariates was performed. RESULTS: Of the 350 LA-HNSCC treated patients, 204 were analyzed. Ninety (44 %) suffered from any grade AKI (grade I 51.1 %): out of them, 84.4 % received high-dose cisplatin (100 mg/m2 q21). On the univariable logistic regression model, male sex, age, serum uric acid, creatinine, concomitant drugs, and cisplatin schedule were significantly associated with a higher rate of AKI. At multivariable model, age (p = 0.034), baseline creatinine (p = 0.027), concomitant drugs (p = 0.043), and cisplatin schedule (one-day bolus or fractionated high-dose vs. weekly; p = 0.001) maintained their significant association. CONCLUSIONS: Identifying pre-treatment risk factors in LA-HNSCC patients may improve decision-making in a setting where cisplatin has a curative significance. A strict monitoring of AKI could avoid cisplatin dose adjustments, interruptions, and treatment delays, thus limiting a negative impact on outcomes.

How to become a Multinational Association of Supportive Care in Cancer-designated center of excellence in supportive care in cancer.

PURPOSE OF REVIEW: Aim of this review is to encourage and involve more doctors to take care of supportive care in cancer patients and to become centers of excellence. RECENT FINDINGS: In 2019, MASCC initiated a certification program to recognize oncology centers that demonstrate best practices in supportive cancer care but literature on how to become MASCC-designated center of Excellence in Supportive Care in Cancer is scarce and will be bulleted. SUMMARY: Becoming centers of excellence means not only the recognition of the clinical and managerial requirements to provide good supportive care but also the creation of a network of centers to participate in multicenter scientific projects and thus improve knowledge in the field of supportive care in cancer patients.

Evaluation of the CNC® prosthetic system in recurrent breast cancer patients with chemotherapy-induced alopecia: a pilot study.

BACKGROUND: Chemotherapy-induced alopecia (CIA), although generally reversible, is felt as extremely distressing by patients with breast cancer. A certified medical device (Capelli Naturali a Contatto®-CNC®) was produced to provide patients with a personalized scalp prosthesis, reproducing the patient's original hair, resistant to any type of everyday or sporting activity, and hairdressing. AIMS: The present study aimed to evaluate the impact of the CNC® device on the patient's perception of their body image, psychological wellbeing, satisfaction, strengths and weakness of the CNC® device. METHOD: A pilot study was carried out on 21 patients affected by CIA due to recurrent breast cancer. A mixed quantitative/qualitative method was used, including administering a questionnaire and a focus group. RESULTS: Based on the Body Image Scale, body image perception improved after 3 and 6 months using the device in the 20 patients who answered the questionnaire. No significant change over time emerged for the six dimensions investigated by the Italian version of the Psychological Well-Being Scale. The thematic analysis of the focus groups showed six themes: definition of the prosthetic device, acceptance of the proposal, experience with the conventional wig, strengths, weaknesses, economic issues. CONCLUSION: Compared to the previous experience of CIA and the standard wig, the use of the CNC® device improved everyday life and may be proposed to women undergoing chemotherapy and expecting alopecia to prevent discomfort, social embarrassment, and compromised body image.

Effectiveness of a phone-based nurse monitoring assessment and intervention for chemotherapy-related toxicity: A randomized multicenter trial.

Purpose: Anticancer treatment-related toxicities can impact morbidity and mortality, hamper the administration of treatment, worsen the quality of life and increase the burden on the healthcare system. Therefore, their prompt identification is crucial. NICSO (Italian Network for Supportive Care in Cancer) conducted a nationwide randomized trial to evaluate the role of a planned, weekly phone-based nurse monitoring intervention to prevent and treat chemotherapy, targeted therapy- and immunotherapy-related toxicities. Here, we report the results from the chemotherapy arm. Methods: This was a nationwide, randomized, open-label trial conducted among 29 Italian centers (NCT04726020) involving adult patients with breast, colon, or lung cancer and a life expectancy ≥6 months receiving adjuvant chemotherapy. Patients received either a weekly nurse monitoring phone call and an educational leaflet reporting practical advice about prevention and treatment of toxicities (experimental group) or the educational leaflet only (control group). Results: The addition of a nurse monitoring intervention may help reduce time spent with severe toxicities (grade ≥3), particularly those less frequently reported in clinical practice, such as fatigue. When considering grade 1-2 AEs, times with mild/moderate diarrhea, mucositis, fatigue and pain were shorter in the experimental arm. Time spent without AEs was significantly longer in the experimental arms for all the toxicities. The requirement for special medical attention was comparable between groups. Conclusion: This study suggests the need for implementing a better system of toxicity assessment and management for patients treated with adjuvant chemotherapy to promote effective preventive and/or therapeutic intervention against these events.

Fears, beliefs, and quality of life of patients with cancer vs the general population during the coronavirus disease 2019 (COVID-19) pandemic in Lombardy.

AIM: To understand how patients with cancer reacted to the coronavirus disease 2019 (COVID-19) pandemic and whether their quality of life (QoL) was affected. METHODS: In June 2020, 111 patients with cancer treated in the supportive care unit of a Comprehensive Cancer Center in Milan and 201 healthy controls from the general population were enrolled and assessed both quantitatively and qualitatively for fears and COVID-19-related beliefs as well as for QoL. RESULTS: Fear of COVID-19 was significantly lower among patients (41% vs 57.6%; p = 0.007), as was fear of cancer (61.5% vs 85.6%; p < 0.001) and other diseases. The perceived risk of getting COVID-19 was lower among patients (25.2% vs 52.7%; p < 0.001), as was the belief of having been exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (18.1% vs 40.8%; p < 0.001). The physical component of QoL was better among the population (54.5 vs 43.8; p < 0.001); the reverse was true for patients' psychological well-being (44.6 vs 39.6; p < 0.001). The qualitative data supported such results, showing a reduced psychological effect on the patients with cancer compared to the controls. Various reasons explain this result, including the awareness of being treated for cancer and nevertheless protected against getting infected in a cancer center of public health reorganized to continue treating patients by protecting them and personnel from the risk of infection. CONCLUSIONS: The experience of a cancer diagnosis, together with proper hospital reorganization, may act as protective factors from fears and psychological consequences of the COVID-19 outbreak.

A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer.

PURPOSE: Fatigue is a distressing symptom in head & neck cancer patients before during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent. METHODS: Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8. RESULTS: The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire. CONCLUSION: The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.

Cognitive decline in older long-term survivors from Non-Hodgkin Lymphoma: a multicenter cross-sectional study.

OBJECTIVES: To compare cognition in a group of older long-term survivors from Non-Hodgkin Lymphoma (NHL) and in a corresponding group of non-cancer controls of the same age. Functional status, polypharmacy and multimorbidity were also evaluated. METHODS: A cross-sectional study was performed in a population of 63 outpatient long-term survivors from NHL, aged 65 or more and 61 non-cancer controls. Socio-demographic, clinical and functional data were collected. Cognitive function was assessed through neuropsychological tests. RESULTS: NHL survivors showed a slightly worse functional status than controls, they were affected by more chronic conditions (3.4 vs 2.3; p = .003) and were taking a higher number of medications (3.4 vs 2.3; p = .03). The Mini Mental State Examination (MMSE) was not significantly different between the groups. NHL survivors performed worse than controls in executive functioning (Trail Making Test B-A 47.9 vs 32.1 p = .04, OR for Stroop test time over 75th percentile in survivors: 2.66; CI 95% 1.04-6.61; OR for Multiple Features Target Cancellation time over 75th percentile in survivors: 2.84; CI 95% 1.10-7.31). A small, statistically significant difference was also observed in verbal memory scores between the two groups. . CONCLUSIONS: The findings of this study suggest that, compared with non-cancer controls, older survivors from NHL may have a lower cognitive performance, especially in the executive functioning and attention domains, regardless of multimorbidity and polypharmacy. Further evidence from larger samples is needed to confirm such findings and better characterize cognitive decline in NHL survivors.

The validation of the Italian version of the COmprehensive Score for financial Toxicity (COST).

PURPOSE: Financial toxicity (FT) is the unintended, potential economic harm or damage of oncologic treatments that has become a medical problem with political implications. To assess FT, the COmprehensive Score for financial Toxicity (COST) questionnaire was developed. Since an Italian version is not available yet, we aimed to validate the Italian version of the COST questionnaire in a population of cancer patients during oncologic treatments or follow-up. METHODS: A sample of Italian native outpatients were asked to fill the Italian version of the COST and five other self-administered questionnaires to assess quality of life, treatment-related symptoms, hope, distress, and unmet needs. Additionally, a subsample of patients was asked to retake the COST after 2-6 weeks. RESULTS: A single factor better represents the scale structure. Internal consistency and test-retest reliability were good. Evidence of convergent and discriminant validity was provided and criterion validity was established, showing that financial toxicity predicts the patient's distress. Finally, known-groups validity was confirmed, testing the differences related to treatment-related expenses, sociodemographic characteristics, stage of the disease, and performance status. CONCLUSION: The current findings suggest the Italian version of the COST is a psychometrically sound scale that potentially offers an added value in assessing FT in patients with cancer.

Interprofessional spiritual care in oncology: a literature review.

Spiritual care is recognised as an essential element of the care of patients with serious illness such as cancer. Spiritual distress can result in poorer health outcomes including quality of life. The American Society of Clinical Oncology and other organisations recommend addressing spiritual needs in the clinical setting. This paper reviews the literature findings and proposes recommendations for interprofessional spiritual care.

Prevalence of Fatigue in Head and Neck Cancer Survivors.

INTRODUCTION: In head and neck cancer (HNC) patients, fatigue is present throughout the course of treatment and during follow-up. There are limited data about the prevalence and factors associated with fatigue in HNC survivors. The objectives of this study were to assess the prevalence of fatigue and its interference with daily life activities and examine the association between fatigue and gender, age, primary tumour site, Human Papillomavirus (HPV) status, previous oncologic therapy, and time since end of treatment. METHODS: Consecutive locally advanced HNC patients having completed curative treatment at least 1 year earlier and free of disease were asked to fill in the Brief Fatigue Inventory (BFI) questionnaire. Fatigue was categorized according to BFI average score as absent (0), mild (>0 to <4), moderate (≥4 to ≤6), and severe (>6 to ≤10). RESULTS: From February 2015 to July 2016, 129 patients (median age = 60 years old; 67% male) were evaluated. Primary sites of cancer were oropharynx (46%, with 4/5 patients HPV positive), nasopharynx (22%), larynx/hypopharynx (14%), oral cavity (13%), and paranasal sinus or salivary gland (5%). Oncologic treatment was completed 12 to 96 months earlier (median = 34 months). Fatigue was reported as absent in 15% of the patients, mild in 67%, moderate in 11%, and severe in 7%. No association between BFI average score and the analyzed variables was identified. DISCUSSION: Moderate and severe fatigue was reported in 18% of HNC survivors. Further research is needed to assess its causes and improve the management.

Fatigue, a major still underestimated issue.

PURPOSE OF REVIEW: Cancer-related fatigue (CRF) is a frequent and distressing symptom present at any stage of the disease. However, it is still underreported, rarely properly assessed and undertreated. RECENT FINDINGS: There are international guidelines available, but also several barriers to their implementation into clinical practice. SUMMARY: According to guidelines, all patients should be clinically screened for CRF on regular basis, at the initial cancer visit and at intervals during every clinic visit, also at posttreatment follow-up visits. Generally, any treatable contributing factors should be identified and possibly treated. After the concomitant factors have been improved or removed, pharmacological and or nonpharmacological treatments of CRF can be considered.Further research is needed to better understand the causes, the better treatments, the easier assessment tool for CRF for clinical practice and to identify barriers and facilitators to implementing CRF guidelines.

Cognitive impairment and chemotherapy: a brief overview.

Patients with cancer are experiencing long-term survival following chemotherapy, but the treatment may also be associated with short and long-term toxicity, including the possibility of cognitive dysfunction. A literature overview indicated a significant association between chemotherapy and cognitive impairment but prospective longitudinal research is warranted to examine the degree and persisting nature of this decline. Although chemotherapeutic agents are unlikely to cross the blood-brain barrier, it has been alleged that the occurrence of neurotoxicity is linked to the pro-inflammatory cytokine pathways. Moreover in most cases many other factors could play an ancillary and concomitant role. The contribution of hormone therapy as well as emotional, social, behavioural and genetic factors should always be considered. Especially physical activity and cognitive training appear promising in the management of cognitive impairment but additional studies are required to establish their efficacy.

Developing drugs in cancer-related bone pain.

INTRODUCTION: Cancer-related bone pain is a frequent and important key problem for metastatic patients that may reduce quality of life, with related limitations in daily activities and morbidity. Often traditional approach to pain may fail given the complex pathophysiology of this phenomenon. METHODS: The aim of this review is to describe promising therapies for cancer-related bone pain, from the pathophysiology to the clinical trials currently ongoing. Moreover, any new evidence for better approach to cancer-related bone pain with the traditional drugs is also considered. CONCLUSIONS: In clinical practice opioids remain the most important pharmacologic treatment for severe pain related to bone cancer. Regard developing drugs, anti-NGF and anti-TrkA are the most investigated new drug in this setting, but a future role in clinical practice is still uncertain.

A supportive care in cancer unit reduces costs and hospitalizations for transfusions in a comprehensive cancer center.

PURPOSE: Among patients with solid or hematologic malignancies undergoing oncologic therapies, blood product transfusions (BPT) are a relevant reason for planned/unplanned hospitalizations, as well as a possible cause of delay in administration of the oncologic therapies. Furthermore, they create additional costs for the healthcare system (HCS). The aim of this study was to compare the costs of performing BPT (erythrocytes and platelets) in medical units/wards to the costs derived from the administration of BPT in a dedicated outpatient supportive care in cancer unit (SCCU). METHODS: Costs were analyzed from June 3, 2009 (when the SCCU started), until December 2013. Four inpatient oncologic units (bone marrow transplantation, radiotherapy, medical oncology I and II) were compared to the SCCU. Data regarding the transfusions performed by the SCCU of the patients who were previously hospitalized for transfusions were extracted, checked, and analyzed through a cross-check on the tax codes. Therefore, patients were considered suitable for the analysis if they had received BPT in the SCCU after a previous hospitalization for transfusion in one of the 4 units/wards. The average daily cost deriving from blood product units and from the hospitalization in each ward (irrespective of pharmaceutical expenses) was compared with the average daily cost deriving from blood product units and from the management of patients in the SCCU. RESULTS: We analyzed 227 patients (112 female) with a mean age of 60 years (range 20-90) with hematologic malignancies in 79% of cases. The number of transfusions performed by the SCCU has grown constantly and consistently over the years, reaching 1,402 transfusions in 2013, thus exceeding the other considered units. The total savings for the HCS was €282.204.71, €151.182.85 in 2013 only. We saved €124.319,26 for each patient transfused at the SCCU. CONCLUSIONS: A dedicated outpatient SCCU, aimed at monitoring and treating cancer therapy-related toxicities and comorbidities and in which it is also possible to perform BPT promptly and effectively, reduces the number of hospitalizations and provides an economical benefit for HCS.

Improving quality of life in patients with advanced cancer: Targeting metastatic bone pain.

Metastatic bone disease in patients with advanced cancer is frequently associated with skeletal complications. These can be debilitating, causing pain, impaired functioning and decreased quality of life, as well as reduced survival. This review considers how the management of metastatic bone pain might be optimised, to limit the considerable burden it can impose on affected patients. Cancer-related pain is notoriously under-reported and under-treated, despite the availability of many therapeutic options. Non-opioid and opioid analgesics can be used; the latter are typically administered with radiotherapy, which forms the current standard of care for patients with metastatic bone pain. Surgery is appropriate for certain complicated cases of metastatic bone disease, and other options such as radiopharmaceuticals may provide additional relief. Treatments collectively referred to as bone-targeted agents (BTAs; bisphosphonates and denosumab) can offer further pain reduction. Initiation of therapy with BTAs is recommended for all patients with metastatic bone disease because these agents delay not only the onset of skeletal-related events but also the onset of bone pain. With evidence also emerging for pain control properties of new anticancer agents, the potential to individualise care for these patients is increased further. Optimisation of care depends on physicians' thorough appreciation of the complementary benefits that might be achieved with the various agents, as well as their limitations. Appropriate anti-tumour treatment combined with early initiation of BTAs and adequate analgesia plays a key role in the holistic approach to cancer pain management and may minimise the debilitating effects of metastatic bone pain.

[Dignity therapy in oncology]. / Terapia della dignità in oncologia.

In oncology, little is known about dignity, dignity-related distress and the issues that influence the sense of dignity for patients. Dignity is personal, subject to changes depending on the experience and the path of life. In oncology some patients feel that their dignity is directly related to the disease, to physical and emotional symptoms, to the highest level of physical and cognitive autonomy and to the continuity of the self. Patient dignity inventory (PDI) is a validate tool designed to measure various sources of dignity-related distress among patients nearing the end of life and serve as a screening tool to assess a broad range of issues that influence the sense of dignity. Dignity therapy is a novel focused psychotherapy consisting in a brief semi-structured interview, audio-recorded and transcribed in order to obtain the "generativity document". The patients are invited to tell about their life history, and to leave words of guidance and offer instructions to pass along to their son, daughters, husband, wife, parents, others. The generativity document is the result of process of emotional and existential care for the patients and a gift for everybody will receive it.