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.
Introduction
The routine use of patient-reported outcomes (PROs) in clinical practice improves quality of care, it helps in reducing the access to emergency services and unscheduled visits, and it ...can improve cancer patients’ time survival. The Edmonton Symptom Assessment System (ESAS) is a PRO largely used in different care settings to monitor physical and psychological symptoms. Nonetheless, along with these symptoms, literature also highlighted the presence and effect of spiritual pain, financial distress, and social isolation on quality of care, treatment effectiveness, and survival.
Aim
The aims of the current study were (a) to complete the Italian version of the ESAS validation process by adding the missing symptom “insomnia” and (b) to develop and validate the ESAS–Total Care (ESAS-TC) that is intended to evaluate and screen not only physical and psychological symptoms but also spiritual pain, discomfort deriving from financial problems associated with illness, and suffering related to social isolation.
Methods
A sample of Italian native outpatients, who referred to the dedicated Supportive Care Unit of the Fondazione IRCCS, Istituto Nazionale deiTumori (INT), Milano, were asked to fill the ESAS-TC to assess item properties, factorial structure, internal consistency, test–retest reliability (patients were asked to retake the scale after 2–6 weeks), and external validity. Concerning the latter, other self-administered scales were employed to assess perceived stress (
Perceived Stress Scale
), unmet needs (using the
Need Evaluation Questionnaire
that describes informative, assistance/care, relational, needs for psycho-emotional support, material needs), and perceived social support (administering the
Multidimensional Scale of Perceived Social Support
that evaluates perceived support of family, friends, and significant others in the wider social field).
Results
The scales were administered to 243 patients with solid (90%) and hematologic (10%) cancers, mean age 62.6, female 76.5%. Analysis suggested that a single factor better represents the structure of the ESAS scales, their internal consistency and test–retest reliability were good, and evidence of construct and criterion validity were provided. Additionally, incremental validity of the ESAS-TC was proved showing that the added items offer a unique contribution in predicting the patient’s stress. Finally, known groups validity was confirmed testing the differences in the ESAS scores due to the Karnofsky Performance Status.
Conclusions
The current study allowed to complete the validation of the Italian version of the ESAS and to develop a psychometrically sound scale, the ESAS-Total Care, that potentially helps in moving cancer research toward personalized total cancer care.
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.
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.
Aim
The aim of the study was to assess the suffering of patients on oncologic treatment and of those no longer on treatment. Preliminarily, we aimed to confirm the psychometric properties of Edmonton ...Symptom Assessment System–Total Care (ESAS-TC) in different stages of the disease. The ESAS-TC screens physical and psychological symptoms, but also spiritual pain, discomfort deriving from financial problems associated with illness, and suffering related to social isolation.
Methods
A sample of consecutive advanced cancer patients on oncologic therapies treated at the Internistic and Geriatric Supportive Care Unit (IGSCU) of Istituto Nazionale dei Tumori, Milano, and of terminal patients no longer on treatment and cared for by the Fondazione ANT palliative home care team were asked to fill the ESAS-TC. In order to strengthen the previous validation study of the ESAS-TC, 3-ULS (to assess social isolation), JSWBS (to assess spiritual well-being), COST-IT (to assess financial distress), and KPS (to assess functional status) were administered too.
Results
The questionnaires were self-reported by 108 patients on treatment (52% >60 years old, female 53%, and 61% with KPS 90–100) and by 94 home care patients (71% >60 years old, female 51%, and 68% with KPS 10–50). The sound psychometric characteristics of ESAS-TC were confirmed. Patients on treatment showed lower total ESAS-TC score (19.3 vs 52.7,
p
<.001) after controlling for age and functional status, and lower financial distress (
p
.<001). Financial distress, spiritual suffering, and social isolation, after controlling for age, showed a significantly higher score in home care patients.
Conclusions
Only through an adequate routine assessment with validated tools is it possible to detect total suffering, the “Total pain” of patients, and treat it through a multidisciplinary approach. The study confirms the reliability and validity of the Italian version of ESAS-TC and the importance of supportive and early palliative care fully integrated with oncological treatment.
Introduction The routine use of patient-reported outcomes (PROs) in clinical practice improves quality of care, it helps in reducing the access to emergency services and unscheduled visits, and it ...can improve cancer patients' time survival. The Edmonton Symptom Assessment System (ESAS) is a PRO largely used in different care settings to monitor physical and psychological symptoms. Nonetheless, along with these symptoms, literature also highlighted the presence and effect of spiritual pain, financial distress, and social isolation on quality of care, treatment effectiveness, and survival. Aim The aims of the current study were (a) to complete the Italian version of the ESAS validation process by adding the missing symptom "insomnia" and (b) to develop and validate the ESAS-Total Care (ESAS-TC) that is intended to evaluate and screen not only physical and psychological symptoms but also spiritual pain, discomfort deriving from financial problems associated with illness, and suffering related to social isolation. Methods A sample of Italian native outpatients, who referred to the dedicated Supportive Care Unit of the Fondazione IRCCS, Istituto Nazionale deiTumori (INT), Milano, were asked to fill the ESAS-TC to assess item properties, factorial structure, internal consistency, test-retest reliability (patients were asked to retake the scale after 2-6 weeks), and external validity. Concerning the latter, other self-administered scales were employed to assess perceived stress (Perceived Stress Scale), unmet needs (using theNeed Evaluation Questionnaire that describes informative, assistance/care, relational, needs for psycho-emotional support, material needs), and perceived social support (administering the Multidimensional Scale of Perceived Social Support that evaluates perceived support of family, friends, and significant others in the wider social field). Results The scales were administered to 243 patients with solid (90%) and hematologic (10%) cancers, mean age 62.6, female 76.5%. Analysis suggested that a single factor better represents the structure of the ESAS scales, their internal consistency and test-retest reliability were good, and evidence of construct and criterion validity were provided. Additionally, incremental validity of the ESAS-TC was proved showing that the added items offer a unique contribution in predicting the patient's stress. Finally, known groups validity was confirmed testing the differences in the ESAS scores due to the Karnofsky Performance Status. Conclusions The current study allowed to complete the validation of the Italian version of the ESAS and to develop a psychometrically sound scale, the ESAS-Total Care, that potentially helps in moving cancer research toward personalized total cancer care.
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.
•Cisplatin is the mainstay of systemic treatment for concomitant chemoradiation in HNC.•Identifying factors to predict early cisplatin-related nephrotoxicity is essential.•Predictive factors were ...age, baseline creatinine, concomitant drugs, CDDP schedule.•Avoidance of CDDP dose adjustments, interruptions, and delays may impact on outcome.
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.
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.
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.
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.
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.
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.
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. .
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 ageing process is characterized by a progressive exhaustion of the naı̈ve T cell reservoir that is accompanied by a compensatory expansion of effector/cytotoxic CD8
+CD28
− T cells. However, the ...origin and function of this subpopulation is not completely clarified. In this study, we examined the intracellular cytokine profile in purified CD8
+ T cells obtained from 29 healthy subjects of different ages. Type 1 (IFN-γ IL-2 and TNF-α) and type 2 (IL-4, IL-6 and IL-10) cytokines were determined in three CD8
+ T subsets, i.e. CD95
−CD28
+ (naı̈ve), CD95
+CD28
− (effector/cytotoxic), and CD95
+CD28
+ (memory). As a general trend, we observed, in aged subjects, an increase of type 1 and type 2 intracellular cytokines within the three CD8
+ subsets. In particular, we showed that type 1 cytokine-positive cells significantly increased, with age, among all the CD8
+ subsets, while a marked increase of type 2 producing cells was observed only in memory CD8
+ T cells. These profound changes are compatible with
inflame-aging, an hypothesis which suggest that immunosenescence is mainly driven by a chronic antigenic load which not only induces an enormous expansion of CD28
− T cells, but also increases their functional activity, exemplified by an high frequency of cells positive for pro-inflammatory cytokines.
