Spirituality is particularly important for patients suffering from life-threatening illness. Despite research showing the benefits of spiritual assessment and care for terminally ill patients, their ...spiritual needs are rarely addressed in clinical practice. This study examined the factor structure and reliability of the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp) in patients with advanced cancer. It also examined the clinical meaning and reference intervals of FACIT-Sp scores in cancer patients subgroups through a literature review.
A forward-backward translation procedure was adopted to develop the Italian version of the FACIT-Sp, which was administered to 150 terminally ill cancer patients. Exploratory factor analysis was used for construct validity, while Cronbach's α was used to assess the reliability of the scale.
This study replicates previous findings indicating that the FACIT-Sp distinguish well between features of meaning, peace, and faith. In addition, the internal consistency of the FACIT-Sp was acceptable. The literature review also showed that terminal cancer patients have the lowest scores on the Faith and Meaning subscales, whereas cancer survivors have the highest scores on Faith.
The Italian version of the FACIT-Sp has good construct validity and acceptable reliability. Therefore, it can be used as a tool to assess spiritual well-being in Italian terminally ill cancer patients. This study provides reference intervals of FACIT-Sp scores in newly diagnosed cancer patients, cancer survivors, and terminally ill cancer patients and further highlights the clinical meaning of such detailed assessment.
Purpose
To describe the physical exercise (PE) habits, lifestyle, and motivation to change toward healthier behaviors in patients newly diagnosed with prostate cancer (PCa).
Methods
A cross-sectional ...study was conducted in an Italian hospital setting. Men newly diagnosed with PCa were consecutively invited to participate in a structured interview that was conducted either in person or by telephone.
Results
The mean age of the 40 participants was 70.5 ± 6.6 (range 50–84). Most participants (65%) reported they were physically active, but more than half of the sample did not reach the recommended PE level. However, 40% of participants would be interested in participating in an exercise program. Only 10% of participants were current smokers, but 90% drank alcohol, and 62.5% were overweight/obese. Almost all participants were not willing to change their habits.
Conclusions
A high proportion of Italian men are insufficiently active when diagnosed with PCa. Moreover, even when exposed to behavioral risk factors, they are not willing to change their lifestyle. Health-care professionals who deal with men newly diagnosed with PCa should take advantage of the teachable moment and apply strategies that support patients’ motivation to exercise and adherence to healthier lifestyles.
Trial registration
The study was prospectively registered in ClinicalTrial.gov NCT03982095 on June 11, 2019.
Intraoperative radiotherapy with electrons (IOERT) boost could be not inferior to external beam radiotherapy (EBRT) boost in terms of local control and tissue tolerance. The aim of the study is to ...present the long-term follow-up results on local control, esthetic evaluation, and toxicity of a prospective study on early-stage breast cancer patients treated with breast-conserving surgery with an IOERT boost of 10 Gy (experimental group) versus 5 × 2 Gy EBRT boost (standard arm). Both arms received whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose).
A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial. Primary endpoints were the evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results. Secondary endpoints were overall survival (OS), disease-free survival (DFS), and patient's grade of satisfaction with cosmetic outcomes.
Between 1999 and 2004, 245 patients were randomized: 133 for IOERT and 112 for EBRT. The median follow-up was 12 years (range 10-16 years). The cumulative risk of IBTR at 5-10 years was 0.8% and 4.3% after IOERT, compared to 4.2% and 5.3% after EBRT boost (p = 0.709). The cumulative risk of out-field LR at 5-10 years was 4.7% and 7.9% for IOERT versus 5.2% and 10.3% for EBRT (p = 0.762). All of the IOERT arm recurrences were observed at > 100 months' follow-up, whereas the mean time to recurrence in the EBRT group was earlier (55.2 months) (p < 0.05). No late complications associated with IOERT were observed. The overall cosmetic results were scored as good or excellent in physician and patient evaluations for both IOERT and EBRT. There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis).
A 10-Gy IOERT boost during breast-conserving surgery provides high local control rates without significant morbidity. Although not significantly superior to external beam boosts, the median time to local recurrences after IOERT is prolonged by more than 4 years.
IntroductionAndrogen deprivation therapy (ADT) and radiotherapy (RT) increase survival in selected patients with prostate cancer. Nevertheless, the side effects of these therapies are associated with ...an increased risk of accidental falls and fractures and a decreased quality of life. Preliminary evidence suggests that physical exercise can be a valid strategy to reduce the side effects of ADT and RT in men with prostate cancer. Despite this knowledge, most patients with prostate cancer are insufficiently active, and there is a lack of data on the safety and adherence to the recommended dose of physical exercise. This study protocol is designed to examine the feasibility and safety of a multicomponent experimental physical exercise intervention targeting psychophysical and cognitive functions and the quality of life in this population.Methods and analysisThis is a pilot feasibility study. Twenty-five men currently treated with ADT and RT for prostate cancer will be invited to participate in a 20-week, multicomponent physical exercise intervention, including supervised and unsupervised exercise sessions and meeting the current recommendation for exercise in cancer. The primary outcomes are physical exercise feasibility (recruitment, adherence and drop-out rates) and safety (adverse events related and unrelated to the intervention). The secondary outcomes are muscle strength, balance, fatigue, symptoms of anxiety and depression, cognitive function, quality of life, and patient satisfaction. We will also record the number of accidental falls and fractures occurring during the intervention and at 1 year of follow-up.Ethics and disseminationThe study has received ethics approval from The Area Vasta Nord Local Ethics Committee (Province of Reggio Emilia, 23 June 2020, Number 520/2020/SPER/IRCCSRE). Recruitment began in September 2020 and will be completed in September 2021. The results will be disseminated through scientific journals and conference presentations.Trial registration numberNCT04500080.
Lockdowns to contain the spread of the SARS-CoV-2 have disrupted routines and behaviors, which could lead to a worsening of lifestyle and an increase in the burden of non-communicable diseases. This ...study aimed to describe the changes in physical activity, diet, alcohol drinking, and cigarette smoking during lockdown. A self-administered online survey addressing adults living in a province in northern Italy was advertised through websites and social media. Citizens could access the survey in anonymity from 4 May until 15 June 2020. A total of 1826 adults completed the survey, with a worsening of physical activity (35.1%), diet (17.6%), alcohol drinking (12.5%), and cigarette smoking (7.7%) reported. In contrast, 33.5% reported an improvement in diet, 12.6% in alcohol drinking, 5.3% in physical activity and 4.1% in cigarette smoking. Female sex, young adult age, suspension of work activity, and symptoms of psychological distress were the factors associated with a greater likelihood of change, which was frequently for the worse. Lockdown had an impact on lifestyle, with some net beneficial effects on diet and mostly negative effects on physical activity. Public health measures should be implemented to avoid long-term negative effects of the lockdown, supporting individuals more prone to change for the worse.
There is a well‐established link between inflammation and cancer of various organs, but little data are available on inflammation‐associated markers of diagnostic and prognostic clinical utility in ...pulmonary malignancy. Blood samples were prospectively collected from 75 resectable lung cancer patients before surgery and in a cohort of 1,358 high‐risk subjects. Serum levels of long pentraxin 3 (PTX3) were determined by high‐sensitivity ELISA. PTX3 immunostaining was evaluated by immunohistochemistry in cancer tissue. Serum PTX3 levels in the high‐risk population were not predictive of developing subsequent lung cancer or any other malignancy; however, serum PTX3 values in patients with lung cancer were significantly higher compared with cancer‐free heavy smokers. With a cutoff of 4.5 ng/ml, specificity was 0.80, sensitivity 0.69, positive predictive value 0.15 and negative predictive value 0.98. The receiver operating curve (ROC) for serum PTX3 had an area under the curve (AUC) of 83.52%. Preoperative serum PTX3 levels in lung cancer patients did not correlate with patient outcome, but high interstitial expression of PTX3 in resected tumor specimens was a significant independent prognostic factor associated with shorter survival (p < 0.001). These results support the potential of serum PTX3 as a lung cancer biomarker in high‐risk subjects. Furthermore, PTX3 immunohistochemistry findings support the role of local inflammatory mechanisms in determining clinical outcome and suggest that local expression of PTX3 may be of prognostic utility in lung cancer patients.
What's new?
To examine the relationship between cancer and inflammation, the authors measured serum levels of pentraxin 3, a “cousin” of C‐reactive protein, in patients with non‐small cell lung cancer. Levels were significantly higher in patients as compared to high‐risk cancer‐free controls, supporting a role for pentraxin 3 as biomarker in lung cancer. Although serum levels did not correlate with clinical outcome, immunostaining of the inflammatory mediator in lung tissue was associated with shorter patient survival, underscoring the pathogenetic relevance of local inflammation in such disease.
Background
Cancer is a life-threatening disease that triggers not only vulnerability to distressing symptoms but also a meaning-making process that may lead to post-traumatic growth. As people often ...struggle to integrate cancer illness into their meaning system to reach an adaptive meaning, psychological interventions focused on a reappraisal of the illness experience can facilitate this process. This multicenter randomized controlled trial (RCT) was primarily aimed at assessing the efficacy of a writing intervention known as a guided disclosure protocol (GDP), compared to a generic writing intervention, in promoting post-traumatic growth in stage I-III breast and colon cancer patients at the end of their adjuvant chemotherapy.
Methods
Between January 2016 and August 2020 recruitment of eligible subjects took place during follow-up clinical consultations. Assessment occurred at baseline (T0), after the intervention (T1, 3 months from baseline), and at 6 months from baseline (T2). Both interventions consisted of three 20-min writing sessions to be performed once every two weeks. Change in post-traumatic growth was assessed using the Posttraumatic Growth Inventory, meaning with the Constructed Meaning Scale, and psychological distress with the Impact of Event Scale and the Hospital Anxiety and Depression Scale.
Results
In the five participating centers, 102 eligible patients were randomized and 72 participants completed follow-up evaluation. Most patients were women (79.4%), had breast cancer (68.6%), and stage I (27.5%), or stage II (44.1%) disease. Mean differences did not reach statistical significance for any of the dependent variables. However, an effect of the GDP, although not statistically relevant, was observed after the intervention in terms of enhanced post-traumatic growth and increased distress measured with the Impact of Event Scale.
Conclusion
This is the first RCT investigating the efficacy of a GDP in cancer patients having post-traumatic growth as the primary aim. Though GDP is a promising intervention in promoting post-traumatic growth, the lack of statistical significance of our findings may be due to the study being underpowered, hence this trial should be replicated with an adequate sample size, paying attention to supporting recruitment.
Clinical trial registration:
ClinicalTrials.gov
, identifier: 2015/0024360.
We compared a standard antihypertensive losartan treatment with a pharmacogenomics-guided rostafuroxin treatment in never-treated Caucasian and Chinese patients with primary hypertension. ...Rostafuroxin is a digitoxigenin derivative that selectively disrupts the binding to the cSrc-SH2 domain of mutant α-adducin and of the ouabain-activated Na-K pump at 10
M. Of 902 patients screened, 172 were enrolled in Italy and 107 in Taiwan. After stratification for country and genetic background, patients were randomized to rostafuroxin or losartan, being the difference in the fall in office systolic blood pressure (OSBP) after 2-month treatment the primary endpoint. Three pharmacogenomic profiles (P) were examined, considering: P1, adding to the gene variants included in the subsequent P2, the variants detected by post-hoc analysis of a previous trial; P2, variants of genes encoding enzymes for endogenous ouabain (EO) synthesis (LSS and HSD3B1), EO transport (MDR1/ABCB1), adducin (ADD1 and ADD3); P3, variants of the LSS gene only. In Caucasians, the group differences (rostafuroxin 50 μg minus losartan 50 mg in OSBP mmHg) were significant both in P2 adjusted for genetic heterogeneity (P2a) and P3 LSS rs2254524 AA 9.8 (0.6-19.0), P = 0.038 and 13.4 (25.4-2.5), P = 0.031, respectively. In human H295R cells transfected with LSS A and LSS C variants, the EO production was greater in the former (P = 0.038); this difference was abolished by rostafuroxin at 10
M. Chinese patients had a similar drop in OSBP to Caucasians with losartan but no change in OSBP with rostafuroxin. These results show that genetics may guide drug treatment for primary hypertension in Caucasians.
Despite the great advances in the concept of palliative care (PC) and its benefits, its application seems to be delayed, leaving unfulfilled the many needs of patients and family members. One way to ...overcome this difficulty could be to develop a new training programme by palliative care specialists to improve PC primary skills in healthcare professionals. The aim of this study was to evaluate the training's impact on trainees within a hospital setting using Kirkpatrick's and Moore's models.
We adopted a mixed-method evaluation with concurrent triangulation. The evaluation followed the first three steps of Kirkpatrick's and Moore's models and included a pre- and post-training evaluation through self-administered questionnaires and focus groups. We used the McNemar statistical test.
The results highlighted the significant amount of knowledge acquired by the hospital professionals after training, in terms of increasing their knowledge of palliative care and in terms of the change in meaning that they attributed to phenomena related to chronicity and incurability, which they encounter daily in their professional practice. In both quantitative and qualitative research, the results, in synthesis, highlight: (i) the development of a new concept of palliative care, centred on the response to the holistic needs of people; (ii) that palliative care can also be extended to non-oncological patients in advanced illness stages (our training was directed to Geriatrics and Nephrology/Dialysis professionals); (iii) the empowerment and the increase in self-esteem that healthcare professionals gained, from learning about the logistical and structural organization of palliative care, to activate and implement PC; (iv) the need to share personal aspects of their professional life (this result emerges only in qualitative research); (v) the appreciation of cooperation and the joining of multiple competences towards a synergistic approach and enhanced outcomes.
It is necessary to further develop rigorous research on training evaluation, at the most complex orders of the Kirkpatrick and Moore models, to measure primary PC skills in health care professionals. This will develop the effectiveness of the integration of I- and II-level palliative care competencies in hospitals and improve outcomes of patients' and families' quality of life.
PDF
