Speckle-Tracking Echocardiography for Cardioncological Evaluation in Bevacizumab-Treated Colorectal Cancer Patients.

Angiogenesis inhibitor Bevacizumab (BVZ) may lead to the development of adverse effects, including hypertension and cardiac ischemia. Whether assessment of changes in myocardial strain by two-dimensional speckle-tracking echocardiography (2D-STE) can be of value in detecting BVZ-mediated cardiotoxicity at an earlier stage is not known. We investigated whether 2D-STE can non-invasively detect early evidence of cardiotoxicity in metastatic colorectal cancer (mCRC) patients treated with BVZ. Between January and June 2019, 25 consecutive patients (71.8 ± 7.5 year/old, 17 males) with mCRC were prospectively enrolled. Patients underwent physical examination, blood tests, and conventional 2D-transthoracic echocardiography implemented with 2D-STE analysis, at baseline and at 3 and 6 months following treatment with BVZ (15 mg/kg every 15 days) + 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX i.v.). At 6-month follow-up, we assessed occurrence of global longitudinal strain (GLS) impairment (> 15% decrease in GLS compared with baseline) as primary end-point and a new-onset systemic hypertension (secondary end-point). On average, GLS showed a progressive significant impairment after BVZ, from - 17.4 ± 3.2% at baseline to - 16 ± 2.9% (p = 0.003) at 6-month follow-up; > 15% decrease in GLS (primary end-point) was detected in 9 patients (36%). All other strain parameters remained unchanged. New-onset systemic hypertension (secondary end-point) was diagnosed in five patients (20%). No significant changes were observed in serial high-sensitivity cardiac troponin I measurements. No patient developed significant changes in LV size or LV ejection fraction; no case of clinically symptomatic HF was observed during BVZ-treatment. Measurement of GLS by 2D-STE analysis can effectively detect BVZ-mediated cardiotoxicity at an early stage.

Nausea and vomiting during the first 3 intercycle periods in chemo-naive cancer patients receiving moderately/highly emetogenic therapy.

AIMS AND BACKGROUND: There is a paucity of data regarding the incidence, intensity, and treatment of nausea and vomiting during the intercycle periods of chemotherapy (CHT). The aims of the study were to assess the incidence and intensity of intercycle nausea and vomiting, to assess the use of rescue antiemetic medications, and to define the more uncomfortable symptom between nausea and vomiting. METHODS: In a prospective study, 108 chemotherapy-naive patients treated with highly or moderately emetogenic CHT for different primary cancers were enrolled. All patients filled out the Edmonton Symptom Assessment System tool before the first cycle of CHT (T0) and on 14-16 days thereafter for the first 3 cycles of CHT (i.e., T1, T2, T3). RESULTS: Sixty-seven patients completed the study. During CHT administration, all patients received antiemetics according to international guidelines. During the intercycle periods, nausea was reported in 6.0% of patients at T0, 10.5% at T1, and 26.9% at T2 and T3, respectively. The intensity of nausea was mild for 6.0%, 21%, and 18% of patients at T1, T2, and T3, respectively; moderate for 1.5%, 3.0%, and 6.0% at T1 to T3; and severe in only 3.0% of patients at any time. Vomiting was present in 1.5% and 10.5% of patients at T2 and T3. Rescue antiemetic medication was required for 41.8% at T1, 53% at T2, and 47.8% at T3. At the end of the study, 70.1% of patients described nausea as the more uncomfortable symptom compared to vomiting. CONCLUSIONS: Nausea has a higher burden of impact over vomiting and should be assessed and treated separately throughout multiple cycles of CHT.

Sexual satisfaction assessment in 194 nonmetastatic cancer patients on treatment or in follow-up.

AIMS AND BACKGROUND: Sexuality is an important aspect of quality of life, but health care professionals still avoid discussing sexual issues with cancer patients. METHODS AND STUDY DESIGN: We present a secondary analysis of sexuality issues according to the results of a survey on 266 patients with early-stage cancer. The aim of the survey was to ascertain the feasibility and clinical usefulness of questionnaires (Patient Dignity Inventory, PDI; Hospital Anxiety and Depression Scale, HADS; Edmonton Symptom Assesssment Scale, ESAS; FACIT-spiritual well-being scale, FACIT-SP; System of Belief Inventory, SBI-15R) investigating aspects such as dignity, hope and research of meaning in life. The present study is an ancillary analysis of the full sample, and we have focused on the results of FACIT-SP about the correlation between sexual satisfaction and clinical characteristics in 108 patients having solid tumors and 86 having hematological malignancies with no metastases who were on active cancer treatment or in follow-up in four different cancer treatment settings during the first half of 2011. RESULTS: The median age of the 194 patients was 65 years, 112 were women, 155 were undergoing treatment and 39 were in follow-up. Eighty-three patients were above the cutoff score for HADS. Among the 171 believers, 80 were churchgoers and 91 were nonchurchgoers, whereas the nonbelievers among the patients were 23. Thirty-five percent of the patients did not respond to the sexuality item of the questionnaire. Among the responders (n = 126), 36% reported having no sexual satisfaction (score = 0). Sexual dissatisfaction was greater in older patients (47% vs 31%, not significant [NS]), women (43% vs 27%, NS), patients on treatment (38% vs 25%, NS), patients who requested psychological support (53% vs 25%, P = 0.001), patients with high levels of anxiety and depression, i.e., HADS scores >10 (44% vs 30%, NS), nonbelievers (61% vs 34% among churchgoers, 29% among believers but nonchurchgoers, P = 0.046). CONCLUSIONS: One out of 3 patients did not respond to the item on sexuality. Among the responders, 1 out of 3 reported having no sexual satisfaction. Half of the patients receiving psychological support considered their sexual life not satisfying. Clinical interviews and specific questionnaires on sexuality should be used to investigate this particular aspect.

The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial.

BACKGROUND: Cancer-related pain continues to be a major healthcare issue worldwide. Despite the availability of effective analgesic drugs, published guidelines and educational programs for Health Care Professionals (HCPs) the symptom is still under-diagnosed and its treatment is not appropriate in many patients. The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients. METHODS/DESIGN: This is a before-after cluster phase II study. After the before assessment, the experimental intervention - the Pac-IFicO programme - will be implemented in ten medicine, oncology and respiratory disease hospital wards. The same assessment will be repeated after the completion of the intervention. The Pac-IFicO programme is a complex intervention with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational program performed through guides from the wards, and an organisational intervention to the ward. The primary end-point of the study is the proportion of cancer patients with severe pain. Secondary end-points include opioids administered in the wards, knowledge in pain management, and quality of pain management. We plan to recruit about 500 cancer patients. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the primary end-point from 20% to 9%. DISCUSSION: This trial is aimed at exploring with an experimental approach the efficacy of a new quality improvement educational intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02035098.

The Edmonton Symptom Assessment System (ESAS) as a screening tool for depression and anxiety in non-advanced patients with solid or haematological malignancies on cure or follow-up.

BACKGROUND: Symptoms' assessment should be considered a clinical practice routine in all cancer stages. The Edmonton Symptom Assessment System (ESAS) is a ten-item patient-rated symptom assessment developed and validated for population affected by cancer in different languages and cultures. The main objective of this study was to assess the performance of ESAS items on anxiety and depression when detecting Hospital Anxiety Depression Scale (HADS) 'cases'. METHODS: A cross-sectional study was carried out on 194 non-advanced patients with solid (108) or hematologic malignancies on cure or follow up, Karnofsky Performance Status ≥ 70, life expectancy > 6 months and no metastases. Patients were assessed by means of ESAS and by HADS. Receiving operator characteristic (ROC) analysis of ESAS anxiety and depression items versus cases of severe (cutoff 11) anxiety and depression according to HADS-specific subscales was performed. RESULTS: Depression and anxiety ESAS items correlated strongly (0.707, Spearman). Area under the curve ranged between 0.84 and 0.96 for the two ESAS items when detecting severe anxiety or depression HADS cases (cutoff = 11). ESAS anxiety or depression scores >3 detected quite well the severe depression HADS cases (Sensibility = 75-Specificity = 84, Sensibility = 87-Specificity = 90, respectively). CONCLUSIONS: Anxiety or depression ESAS items score >3 can be applied as a useful, easy and not time consuming screening tool for assessing anxiety and depression in non-advanced patients with solid or haematological malignancies.

Hope Herth Index (HHI): a validation study in Italian patients with solid and hematological malignancies on active cancer treatment.

AIMS AND BACKGROUND: Although hope is a widely used term, the experience of hope in patients with chronic or even life-threatening diseases is often disregarded due to the scarcity of carefully designed and validated assessment tools. The aim of this study was to validate the Hope Herth Index (HHI) questionnaire in the Italian population of patients with solid or hematological malignancies during active cancer treatment. METHODS: After the translation procedures, the psychometric properties of the Italian version of HHI were evaluated in 266 patients with non-advanced cancer cared for in four different settings. Summative scores ranged from 12-48, with a higher score denoting greater hope. Confirmative factorial analysis was performed to assess dimensionality. The test-retest reliability was assessed by means of the Lin concordance coefficient (two weeks' interval, 80 patients). Concurrent validity was assessed through the following questionnaires: Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), Edmonton Symptom Assessment Scale (ESAS), and System Belief Inventory (SBI-15R). RESULTS: A total of 266 patients were enrolled. Confirmative factor analysis did not confirm the original three-factor solution, whereas a one-factor solution did perform well. Cronbach's alpha was 0.84 and the test-retest reliability was 0.64 (95% CI 0.51; 0.76). Large convergence was found with spiritual well-being as measured by the FACIT-Sp (0.69) and with anxiety-depression as measured by the HADS (inverse correlation: -0.51). Physical symptoms and religiousness were only slightly correlated, as expected. CONCLUSIONS: The Italian version of HHI is a valid and reliable assessment tool - useful to initiate conversation with someone who is troubled but finds it difficult to talk - in patients with either solid or hematological malignancies on active cancer treatment during the non-advanced stages of the disease.

Treatment of osteonecrosis of the jaw (ONJ) by medical ozone gas insufflation. A case report.

Osteonecrosis of the jaw (ONJ) is an adverse event reported in patients receiving cancer treatment, especially bisphosphonates and denosumab. A patient with multiple myeloma who underwent up to 22 intravenous zoledronic acid infusions without previous dental examination developed a devastating ONJ lesion in the right horizontal mandibular ramus. He was treated with local ozone gas applications every third day by means of a special bell to avoid O(3) diffusion. Azithromycin 500 mg/day was administered for 10 days prior to the O(3) applications. O(3) therapy resulted in sequestration of the necrotic bone after a median of 15 applications, following which surgery was necessary to remove it. Interestingly, removal was possible without the resection of the healthy mandible edge because of the presence of the bone sequestrum. Medical O(3) gas administration was effective and safe in a patient treated with bisphosphonates who developed a >2.5 cm ONJ lesion. Future research is needed to demonstrate the efficacy and tolerability of such treatment in a larger number of patients.

Is the spiritual life of cancer patients a resource to be taken into account by professional caregivers from the time of diagnosis?

BACKGROUND AND AIM: Spiritual life can be defined as the search for personal contact with the transcendent. Careful assessment of spiritual life can help to value its importance to cancer patients from the moment of their diagnosis. METHODS: This is a cross-sectional study. Two hundred fifty-seven patients undergoing cancer treatment filled in the validated Italian version of the Systems of Belief Inventory (SBI-15R). Patients were also asked to attribute themselves to one of the following, mutually exclusive categories: believer and churchgoer, believer but no churchgoer, and non-believer. RESULTS: Five patients did not report their religious stance and were therefore excluded from the analysis. Of the remaining 252 patients, 49% declared to be believers and churchgoers, 43% believers but not churchgoers, and 8% non-believers. Of the 20 cancer patients who declared not to have a religious faith, 7 patients agreed with the statement that they felt certain that God exists in some form, and 4 had experienced peace of mind through prayer and meditation. Almost all of the patients who declared to have a religious faith and to be churchgoers explicitly affirmed to have been helped by prayer and meditation in coping with their illness. Among believer churchgoers, only 30% declared to seek out the religious or spiritual community when they needed help. CONCLUSIONS: A large proportion of cancer patients find themselves involved with the search for a personal contact with the transcendent, also beyond any specific religious affiliation. These spiritual issues may be important even when they are not expressed as participation in religious rituals or adherence to specific religious beliefs. On the other hand, participation in religious rituals often implies the need for a personal spiritual life, both through those rituals and beyond them, as through personal prayer and meditation. These results ask for more attention on the part of professionals towards spiritual resources among cancer patients. It might be appropriate to look systematically for these resources from the moment of the diagnosis, through the sensitive administration of an easy and valid assessment tool like the SBI-15R.

[Project "Hospital without pain": analysis of the Italian situation before the law 38]. / Progetti "ospedale senza dolore": analisi della realtà italiana prima della legge 38.

Project "Hospital without pain": analysis of the Italian situation before the law 38. Background. Some years ago, the project "Pain free Hospital" started in Italy to improve standards of pain management. Recently, Italian government passed a new law, which sets patient's right to receive palliative care and pain therapy. Aim. To evaluate pain prevalence in Italian hospitals before the new Italian law, analyzing the articles published within the project "Pain free Hospital". Methods. We did a Medline research using the following key words: pain; "Pain free Hospital"; cancer patients; Italian; Italy, from 1995 to 2010, and contacted all Italian centers of pain therapy. Results. Six articles met inclusion criteria. Pain prevalence was unexpectedly high in all the studies examined, albeit with wide differences among hospitals (37,7%-91%). Discussion. Our research shows that pain is not adequately controlled in Italian hospitals, probably for many reasons (wards organization, difficulty in prescribing opioids, etc.) but, above all, due to "opiophobia". The new Italian law should guarantee better analgesic treatments for all patients with persistent pain, both oncological and non oncological.

Modern computer technologies facilitate communication with a young cancer patient.

AIM: The aim of this paper is to show how new technologies may help the communication process in clinical practice in a department providing supportive care to patients undergoing cancer treatment. METHOD: Communication via Internet chat between the psychologist and a young man who sees chatting on the Internet as a natural and familiar mode of expression was shown to be useful. RESULTS: The Internet link enabled us to open a communication channel with the patient and to have a conversation that would otherwise have been impossible. CONCLUSIONS: Although verbal communication is the most important way to communicate among people, Internet communications are certainly an opportunity worth exploring, because they may open up new channels for cancer patients whose ability to speak is restricted. We might imagine using this approach in pediatric oncology, with adolescents and preadolescents, and with young adults like the patient discussed here. The case discussed highlights the enormous difference between the mere transfer of information and genuine communication, the latter involving an encounter with the patient.

System of belief inventory (SBI-15R): a validation study in Italian cancer patients on oncological, rehabilitation, psychological and supportive care settings.

AIMS AND BACKGROUND: Spiritual and religious needs are part of a patient's clinical history. The aim of the study was to validate the System of Belief Inventory (SBI-15R) in Italy. It is a feasible way to collect useful information on spiritual needs and resources of patients at any stage of the disease. METHODS: After the translation procedure, the psychometric properties of the Italian version of SBI-15R were evaluated in patients with non-advanced cancer cared for in four care settings. All patients were administered the Italian version of SBI-15R together with an hoc item inquiring about spirituality--"I believe I am a spiritual person", which was supposed to be correlated with the SBI-15R score. RESULTS: A total of 257 patients were enrolled (mean age, 53.6 years; 191 females, 50% breast cancers, 12% had mestastases). As regards spirituality and religious beliefs, 47.9% were churchgoers; 42% believers but not churchgoers, and 7.8% non-believers; 86.7% of the patients were catholic. The construct validity was high both for the Belief Scale (Cronbach alpha = 0.946) and for the Support Scale (Cronbach alpha = 0.897). The mean (+/- SD) SBI-15R scores of the different groups of patients (known-groups validity) for the "Support" scale was 9.7 (+/- 3.4) for churchgoers, 4.9 (+/- 3.2) for believers non-churchgoers, and 0.8 (+/- 1.4) for non-believers (P < 0.0001, F test). For the "beliefs" scale, it was 25.4 (+/- 4.8) for churchgoers, 18.1 (+/- 6.3) for believers non-churchgoers, and 3.4 (+/- 3.5) for non-believers (P < 0.0001, F test). Regarding the test-retest reliability (n = 68), Lin's concordance correlation for the "Support" scale was 0.890 (0.841; 0.939 95% CI) and for the "Belief" scale was 0.969 (0.955; 0.984 95% CI). The correlation between the statement "I believe I am a spiritual person" and the SBI-15R scores was 0.475 for the "Support" scale and 0.473 for the "Belief" scale." CONCLUSIONS: The Italian version of SBI-15R is a valid and reliable assessment tool to evaluate religiousness and spirituality in cancer patients.