A Prospective Study Evaluating Health-Related Quality of Life Following a Multimodal Treatment for Colorectal Cancer.

PURPOSE: The major improvements in the diagnosis and treatment of colorectal cancer (CRC) over the past decades increased the patients' survival rates. Despite this, patients and clinicians still need to address the long-term physical and psychosocial effects over time. This paper aims to prospectively assess CRC patients' HR-QoL psychological distress and sexual functioning and identify clinical, demographic, and psychological predictors. METHODS: In total, 55 patients were evaluated from diagnosis to 5-year follow-up with the following instruments: EORTC QLQ-C30 and QLQ-C38 for QoL and sexuality; HADS for psychological distress; and specific questions to detect psychological variables. RESULTS: QoL worsened after diagnosis and returned to baseline values after 5 years. Sexual function significantly deteriorated over time (with no recovery, especially in women), while borderline/severe anxiety and depression decreased. A better HR-QoL at baseline was associated with better physical, social and sexual functioning, positive body image and sexual pleasure after 5 years. CONCLUSION: HR-QoL allows the early detection of patients at risk, favoring prompt patient-centered interventions.

The immersive experience of virtual reality during chemotherapy in patients with early breast and ovarian cancers: The patient's dream study.

Background: A virtual reality experience (VRE) could represent a viable non-pharmacological intervention to reduce and better manage the main factors of psychophysical distress related to the diagnosis and treatment of cancer. Aim: The "Patient's Dream" study was a two-arm randomized controlled trial conducted at the Regina Elena National Cancer Institute - IRCCS (Rome, Italy) from April 2019 to January 2020 to evaluate VRE impact in patients affected by breast or ovarian cancer. Before starting the first cycle of chemotherapy (CT), patients were randomized to receive the VRE (VRE arm) as "distraction therapy" or to entertain themselves with conventional means (control arm). The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity. Results: Fourty-four patients were enrolled, 22 patients were randomly assigned to the VRE arm and 22 to the control arm. Collected data underline the absence of prevalent disturbs of anxiety and depression in both groups. Nevertheless, even if the state anxiety values before and after CT decreased in both groups, this reduction was statistically significant over time only in the VRE arm. The duration of therapy perceived by patients undergoing distraction therapy was significantly shorter when compared to the control group. The use of VRE during the first CT cycle appeared to reduce asthenia outcomes. Conclusion: Obtained data suggest that the VRE positively influenced the levels of state anxiety among cancer patients and support the continuous research on VRE as a distraction intervention, with the aim to meet the clinical need for effective nonpharmacologic adjunctive therapies. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT05234996, identifier NCT05234996.

Use of rehabilitation pathways in women with breast cancer in the first 12 months of the disease: a retrospective study.

BACKGROUND: Breast cancer (BC) presents important physical and psychological challenges that should be appropriately addressed through continuous, integrated and individualized rehabilitation programs after treatment. In this study, we aimed to collect more information on the rehabilitation patterns and utilization of healthcare services by women with BC. METHODS: We retrospectively analyzed data from two archives of the Lazio Regional Health System Database to assess rehabilitation patterns in women diagnosed with BC in the Lazio region (Italy) in 2008. RESULTS: A total of 5538 women diagnosed with BC were considered in the present study. Most patients (81.7%) received outpatient rehabilitative care, consisting mainly of pathology-related interventions and, more rarely, disability-related interventions (mainly motor rehabilitation and rarely cognitive or psychological therapy). Few patients followed an inpatient (1.3%) or an intensive outpatient rehabilitation program (1.0%). CONCLUSION: Most patients do not receive adequate rehabilitation care during the first year after diagnosis. More information and better rehabilitation services should be provided to help patients with BC access rehabilitation programs. The study also suggests the importance of psychosocial and cognitive interventions, which is a major unmet need in women with BC.

Symptoms and their implications on quality of life and psychological distress in sarcoma patients.

The aim of this study was to investigate symptoms, their variation over time and their relationship with quality of life (QoL)/psychological distress in sarcoma patients, as few data regarding QoL and psychological distress in this set of patients are currently available. A total of 188 sarcoma patients from an Italian referral center were involved. Symptoms and financial difficulties were evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire from the first treatment and over the follow-up period, up to 6 years. The authors found that patients with sarcoma experience several symptoms, especially fatigue and pain, which may dramatically worsen QoL and psychological distress. In conclusion, patients with sarcoma often experience fatigue, pain and financial difficulties, which negatively impacts QoL and psychological distress. To ameliorate overall QoL, proper control of symptoms is necessary.

The Experience of Oncology Healthcare Providers in the Central Italy during the COVID-19 Lockdown.

While the emotional response of healthcare providers during the COVID-19 pandemic has been extensively investigated in countries in the Far-East, little is known about the psychological impact and the associated emotional distress of healthcare providers in Italy, especially with regard to different regions. The aim of the "VIRARE" survey, which was addressed to all the healthcare providers in the Lazio region (central Italy) and, in particular, to those working in the oncology field, is to analyze their opinion on the impact and management of the pandemic, to better understand the level of their psychological distress. A global good psychological response of healthcare providers to the pandemic has emerged, independently from their different occupations in the oncology field. Healthcare providers show a high degree of resilience, identifying the major causes of distress the difficulty of the management of this situation, the obstacles in their working activity and expressing a high degree of dissatisfaction with how Italian institutions handled this situation. This survey also provides a direct comparison between COVID-19-infected (or directly in contact with COVID-19-infected patients) and uninfected healthcare providers, identifying the sub-category of infected professionals that reported signs of depression as particularly vulnerable.

Sarcoma patients' quality of life from diagnosis to yearly follow-up: experience from an Italian tertiary care center.

Aim: To investigate sarcoma patients' perception of quality of life and psychosocial distress across the different disease's stages. Patients & methods: Total 329 sarcoma patients were monitored from diagnosis up to a maximum of six consecutive follow-up visits. Results: Functional status worsened over time with the lowest value after surgery and a full recovery not earlier than the second follow-up visit. Married and single patients exhibited similar quality of life pattern. High levels of psychological distress were observed from diagnosis to active treatment periods with a progressive improvement during follow-up. Psychological distress pattern over time varied by marital status and age. Conclusion: Our study suggests the importance of integrating psychosocial care to medical therapy across the entire sarcoma journey.

The unmet need for oncofertility preservation in women: Results of a survey by different oncological specialists in Lazio, Italy.

In recent years, we have witnessed a growing interest in the prevention of the loss of reproductive efficacy in young women as a result of cancer or its treatments. Indeed, recent studies have shown that loss of fertility impacts deeply on young women and sometimes may be even more stressful than the cancer diagnosis itself. In fact, the risk of treatment-associated infertility and premature menopause is a major concern for patients. Nevertheless, the approach to fertility preservation in women diagnosed with cancer is far from being standardized, and counseling strategies are poorly adopted in clinical practice. In Italy, the federal structure of public health makes it difficult to refer patients to local referral centers experienced in fertility preservation. In particular, a need exists to identify oncologists in the Lazio region specialized in fertility preservation and those facilities who are able to counsel patients regarding their sexuality. For these reasons, the Lazio section of Italian Association of Medical Oncology has led an oncofertility and oncosexuality survey to assess deficiencies in the path to start fertility preservation procedures and to help patients with cancer-related sexual problems. In total, 273 healthcare providers participated in the survey. Overall, the participants had a low interest in their patients' infertility problems, which led to a poor referral of patients to fertility preservation centers. This behavior demonstrated by healthcare providers is attributed to the necessity to rapidly start oncological treatments, the lack of knowledge of referral centers, and the little experience in tackling the subject with the patients. The interviewees also recognize communication difficulties related to lack of information on issues, absence of rehabilitations paths, and embarrassment.

The course of cancer related fatigue up to ten years in early breast cancer patients: What impact in clinical practice?

Little is known about the cancer related fatigue (CRF) along cancer course and risk factors that could predict CRF development and persistence in breast cancer (BC) survivors. This prospective study detected incidence, timing of onset, duration of CRF, impact on QoL and psychological distress. Seventy-eight early BC patients, undergoing chemotherapy (CT) followed or not by hormonal therapy were assessed for QoL and psychological distress by EORTC QLQC30 and HADs questionnaires. Fatigue was investigated with mix methods, structured interview and psychometric measures. A qualitative analysis was added to assess the behavioral pattern of CRF. Low fatigue levels were identified after surgery (9%), increasing during (49%) and at the end of CT (47%), maintaining after 1 year (31%) and declining up to ten years of follow-up. Prevalence of CRF was higher at the end of CT and lower at follow-up. At the end and after 1 and 2 years from CT, persistence of CRF was associated to anxiety in 20%, 11% and 5% and to depression in 15%, 10% and 5% respectively. A relationship between CRF and psychological distress was observed; patients presenting depression and anxiety before CT were at higher risk for fatigue onset at a later period. A relationship between fatigue and QoL was noted at the end of CT. Our study shows the fatigue timely trend in early BC patients from surgery, CT and follow-up. Identification of biological, psychological, social predictor factors related to fatigue could be helpful for early interventions in patients at higher risk of developing fatigue.

Rehabilitation pathways in adult brain tumor patients in the first 12 months of disease. A retrospective analysis of services utilization in 719 patients.

PURPOSE: Although previous studies have demonstrated the efficacy of rehabilitation programs for brain tumor (BT) patients and the positive impact on quality of life of functional gain, there are few studies focusing on specific rehabilitation management of brain tumor patients. METHODS: With the aim to evaluate the pattern of rehabilitation care and health services utilization in patients with brain tumor, we retrospectively analyzed administrative data on a large cohort of brain tumor patients diagnosed during the period 2008-2009 in the Lazio Region. Pattern of rehabilitation care was analyzed during a follow-up of 12 months after diagnosis. Data for this study were gathered and linked from two sources: (1) hospital discharge records stored into the Lazio Regional Health System database and (2) rehabilitation pathways database including inpatient and outpatient interventions files. RESULTS: We identified 789 patients with an ICD-9-CM code of 191.** in the Regional Health System databases in the study period. Among 719 patients included in this study, 92 (12.8 %) were treated with inpatient rehabilitation program, 22 (3.1 %) received an outpatient personalized program with intensive rehabilitation plan, and 85 (11.8 %) received outpatients rehabilitation interventions. CONCLUSIONS: Our retrospective analysis on the rehabilitation service utilization in a large cohort of BT patients shows that a limited number of patients received rehabilitation interventions during the first year after diagnosis. Nevertheless, the rehabilitation needs in BT patients are largely unmet and the lack of defined physical and cognitive rehabilitation strategies may negatively affect the functional independence and the short- and long-term quality of life.

Autoantibodies specific to estrogen receptor alpha act as estrogen agonists and their levels correlate with breast cancer cell proliferation.

Estrogen receptors have recently been demonstrated at the cell surface. Unlike nuclear receptors, they are able to trigger rapid responses inside the cells. In this study, we evaluated the presence and the possible role of autoantibodies specific to estrogen receptor (anti-ER Abs) in the peripheral blood of breast cancer patients. Anti-ERα Abs were detectable in 22/48 (46%) patients' sera and their levels positively correlated with the percentage of Ki-67-positive breast cancer cells. Anti-ERα Abs purified from breast cancer patients' sera were able: (i) to recognize ERα epitopes expressed at the cell surface of ER-positive breast cancer cells, (ii) to trigger rapid extracellular signal-regulated kinase (ERK) phosphorylation, and (iii) to induce cell proliferation. Our results suggest that anti-ERα Abs can act as estrogen agonists playing a pathogenetic role as breast cancer-promoting factors. These autoantibodies could also be considered as possible peripheral blood biomarkers indicative of the breast cancer growth potential.

National Cancer Information Service in Italy: an information points network as a new model for providing information for cancer patients.

The international literature data report that good information and communication are fundamental components of a therapeutic process. They contribute to improve the patient-health care professional relationship, to facilitate doctor-patient relationships, therapeutic compliance and adherence, and to the informed consent in innovative clinical trials. We report the results of a multicentric national initiative that developed a 17-information-structure network: 16 Information Points located in the major state-funded certified cancer centers and general hospitals across Italy and a national Help-line at the nonprofit organization AIMaC (the Italian oncologic patients, families and friends association), and updated the already existing services with the aim to create the National Cancer Information Service (SION). The project is the result of a series of pilot and research projects funded by the Italian Ministry of Health. The Information Service model proposed is based on some fundamental elements: 1) human interaction with experienced operators, adequately trained in communication and information, complemented with 2) virtual interaction (Help line, Internet, blog, forum and social network); 3) informative material adequate for both scientific accuracy and communicative style; 4) adequate locations for appropriate positioning and privacy (adequate visibility); 5) appropriate advertising. First results coming from these initiatives contributed to introduce issues related to "Communication and Information to patients" as a "Public Health Instrument" to the National Cancer Plan approved by the Ministry of Health for the years 2010-2012.

Sexual dysfunction following surgery for rectal cancer - a clinical and neurophysiological study.

BACKGROUND: Sexual dysfunction following surgery for rectal cancer may be frequent and often severe. The aim of the present study is to evaluate the occurrence of this complication from both a clinical point of view and by means of neurophysiological tests. METHODS: We studied a group of 57 patients submitted to rectal resection for adenocarcinoma. All the patients underwent neurological, psychological and the following neurophysiological tests: sacral reflex (SR), pudendal somatosensory evoked potentials (PEPs), motor evoked potential (MEPs) and sympathetic skin responses (SSRs). The results were compared with a control group of 67 rectal cancer patients studied before surgery. Only 10 of these patients could be studied both pre- and postoperatively. 10 patients submitted to high dose preoperative chemoradiation were studied to evaluate the effect of this treatment on sexual function. Statistical analysis was performed by means of the two-tailed Student's t test for paired observations and k concordance test. RESULTS: 59.6% of patients operated reported sexual dysfunction, while this symptom occurred in 16.4% in the control group. Moreover, a significantly higher rate of alterations of the neurophysiological tests and longer mean latencies of the SR, PEPs, MEPs and SSRs were observed in the patients who had undergone resection. In the 10 patients studied both pre and post-surgery impotence occurred in 6 of them and the mean latencies of SSRs were longer after operation. In the 10 patients studied pre and post chemoradiation impotence occurred in 1 patient only, showing the mild effect of these treatments on sexual function. CONCLUSION: Patients operated showed severe sexual dysfunctions. The neurophysiological test may be a useful tool to investigate this complication. The neurological damage could be monitored to decide the rehabilitation strategy.

An integrated psychological strategy for advanced colorectal cancer patients.

BACKGROUND: There is evidence regarding the usefulness of psychosocial intervention to improve health related quality of life (HRQOL) in adult cancer patients. The aim of this report is to describe an integrated approach and to evaluate its feasibility in routine clinical practice in 98 advanced colorectal cancer (ACC) patients during chronomodulated chemotherapy. METHODS: A prospective non-randomised design was developed and applied in a cancer out-patient setting. The intervention consisted of an integrated approach, whereby the psycho-oncologist had an active role in the health care team with the physician and routinely included psychological understanding in the medical treatment program. The psychological evaluation assessed: a) adaptation, awareness, psychopathological disorders through a psychodynamic interview; b) anxiety and depression using the HAD scale; c) subjective perception of care quality through a structured interview and d) HRQOL evaluation assessment with the EORTC QLQ C30. Outcomes data were collected before and after 18 weeks of chemotherapy. RESULTS: After 18 weeks of chemotherapy a significant improvement of adaptation and awareness was observed. The HADs results showed a significant decrease in anxiety when compared to pre-treatment. The structured interview showed a significant increase of patients who positively experienced the impact of medical treatment on HRQOL, anxiety, depression, interpersonal relationships, free-time and who positively experienced the care quality. Indeed, a majority of patients positively experienced the team relationship modality during the whole treatment. All scales on the EORTC questionnaire remained unchanged during the entire treatment. CONCLUSION: Our results suggest that it is feasible to carry out an integrated approach during chemotherapy. These results seem to support the integrated approach as a tool in aiding advanced colorectal cancer patients' ability to cope with their diagnosis and treatment although an appropriately designed study is required to confirm this.

High-dose chronomodulated infusion of 5-fluorouracil (5-FU) and folinic acid (FA) (FF5-16) in advanced colorectal cancer patients.

PURPOSE: The best way to deliver infusional 5-fluorouracil (5-FU) and folinic acid (FA) has yet to be determined. The aim of this prospective phase II trial was to verify the tolerability, activity and efficacy of chronomodulated 5-FU-FA (FF(5-16)) every 3 weeks in 48 untreated patients (group A), and 28 pretreated and four non-measurable, advanced colorectal cancer (ACC) patients (group B). METHODS: The sinusoidal delivery of both drugs started at 10.00 p.m. and ended at 10.00 a.m., with peak flow at 4.00 a.m. for 5 consecutive days. The initial 5-FU dose was 900 mg/m(2)/day with intra-patient dose increase at 1,000 and 1,100 mg/m(2)/day, at the second and third course, respectively; FA was injected at a fixed dose of 150 mg/m(2)/day (Garufi et al.1997). RESULTS: Neither death from toxicity nor hematological toxicities were encountered. Maximal toxicity consisted of Grade 3 oral mucositis in 41% of patients, in only 8% of 535 courses. It was possible to achieve objective responses in 31% of untreated patients, with a progression free survival (PFS) of 7 months, median survival of 14 months and a 2-year survival rate of 28%. Similar results for PFS and survival were obtained in pretreated patients as well. Univariate analysis and multivariate analysis showed that response was related to the occurrence of mucositis and diarrhea ( p=0.03 and p=0.0007) and to performance status (PS) ( p=0.01). Quality of life, measured with the EORTC QLQ-C30+3 questionnaire, was unaffected by treatment and was better in patients with good PS and responsiveness. CONCLUSIONS: In this chronomodulated FF(5-16) phase II study, the probability of obtaining a relevant tumor reduction was significantly correlated with a patient variable such as PS, and toxicity variables such as mucositis and diarrhea. This observation and the validation of predictive factors for QoL deserve further investigation in ACC patients.