Sexual health-a topic for cancer patients receiving oncological treatment with palliative intent.

OBJECTIVES: Sexuality is an important dimension of health-related quality of life (HRQOL) in cancer patients. Studies evidence that most patients report impairments of their sexual health related to their disease or its treatment. The Quality of Life Group of the European Organization for the Research and Treatment of Cancer (EORTC) developed a patient reported outcome measure assessing multidimensional aspects of sexual health. The validation study for this instrument revealed heterogenous results for patients in palliative oncological treatment. The aim of this secondary analyses is to examine differences in patient related sexual health outcomes between palliative patients with good performance status (GPS) and those with poor performance status (PPS). METHODS: In this observational cohort study, self-reported sexual health issue scores were compared between the two groups of patients in palliative oncological treatment with GPS vs PPS status. RESULTS: Patients with GPS experienced significantly more sexual satisfaction than patients with PPS (p = 0.015). They reported significantly more treatment effects on their sexual activity (p = 0.005) and suffer more from decreased libido (p = 0.008). Patients with PPS reported significantly more fatigue (p = 0.03) and regarded preservation of sexual activity of higher importance than did patients with GPS (p = 0.049). CONCLUSIONS: Our study demonstrates the importance of sexuality for patients in palliative oncological treatment, especially for those with limited performance status. Considering the patients´ perspective, sexual health reaches beyond physical functioning. Patients in a palliative phase of disease report high levels of psychosexual problems while sexual performance deteriorates. Sexuality is an important aspect of HRQOL for these patients, needs to be addressed by health care providers and sensitively integrated into palliative care plans.

International collaboration for assessing unmet needs of cancer survivors and family caregivers: Lens of healthcare professionals.

OBJECTIVE: Cancer patients and their family caregivers have reported various needs that are not met. Recognition of the unmet needs by healthcare professionals may be a first step to adequately and systematically addressing them. Thus, the International Psycho-Oncology Society Survivorship Online Survey was developed to measure healthcare professionals' evaluation about the unmet needs of their patients and family caregivers around the globe. METHODS: The survey was developed in English and translated to additional 14 different languages. The survey was distributed on the web-based REDCap application to over 50 psycho-oncology societies and their networking platforms as well as social media and to authors who have published in psycho-oncology journals globally. RESULTS: A total of 1472 participants from 36 countries at least partially completed the survey. Healthcare professionals evaluated needs for managing one's emotional distress and patients' medical care and symptoms as the most common concerns for both patients and their family caregivers across all patient age groups. Less than two-thirds of the participating healthcare professionals reported that their institution had services or programs to address the needs of the patients or caregivers. CONCLUSIONS: Findings suggest several directions for further analyses to provide more specific information that would be readily translated into clinical practices, research, and policy aimed to enhance the quality of life of cancer patients, survivors, and family caregivers around the globe. In addition, this collaborative effort also hints at the importance of establishing international networks to promote equity in care for people touched by cancer worldwide.

Healthcare providers' perceptions about the unmet needs of their patients with cancer across healthcare systems: results of the International Psycho-Oncology Society survivorship survey.

OBJECTIVE: Systematic understanding of patients' unmet needs is essential for providing effective supportive care. This study sought to compare the unmet needs of patients with cancer identified by health care providers (HCPs) among four major healthcare systems. METHODS: HCPs (n = 247) participated in the International Psycho-Oncology Society (IPOS) Survivorship Online Survey, evaluating their patients' unmet needs. The country of HCPs was grouped into four major healthcare systems: Beveridge model, Bismarck model, National Health Insurance model, and out-of-pocket model. RESULTS: Most HCPs were from countries with the Bismarck model. Substantial levels (> 50%) of unmet needs in all domains are reported across the four healthcare systems. Pediatric patients/survivors living in countries under out-of-pocket healthcare model were evaluated to have less unmet needs for managing decline in physical or cognitive functioning and insomnia/sleep difficulty/fatigue, than those in countries under Beveridge, Bismarck, and National Health Insurance models. Moreover, middle-aged patients/survivors under Beveridge and National Health Insurance models were likely to have greater unmet needs for dealing with cancer-related financial concerns than those under Bismarck model. CONCLUSION: This study provides valuable insights into the unmet needs of patients with cancer in different healthcare systems, highlighting the significance of targeted interventions to address the unique needs of patients across diverse healthcare systems. Further investigation is warranted to identify the system factors associated with patients' unmet needs, enabling the development of effective healthcare policies and interventions to comprehensively address the multifaceted needs of patients with cancer.

Risk perception, treatment adherence, and personality during COVID-19 pandemic: An international study on cancer patients.

OBJECTIVE: To explore the role of personality traits in moderating the relation between COVID-19 risk perception and treatment adherence, and between risk perception and psychosocial distress in patients diagnosed with cancer. METHODS: An online survey (n = 1281) was conducted worldwide in seven countries (Austria, Germany, Hong Kong, Italy, Spain, Sweden, and Turkey). Inclusion criteria were to be 18 years of age or older, have received a cancer diagnosis, and be in treatment or follow-up. A few moderated regression models were performed with both personality traits and Hierarchical Taxonomy of Psychopathology super-spectra as moderators. RESULTS: Detachment, negative affectivity, psychoticism and all the super-spectra significantly moderated the relation between coronavirus risk perception and psychosocial distress, after the adjusting effect of confidence in safeguards. Only negative affectivity moderated the association between coronavirus risk perception and treatment adherence. CONCLUSIONS: Personality traits may foster the understanding of how a patient might adjust to cancer treatment and, more generically, to highly stressful events such as the COVID-19 pandemic. Further research is needed to confirm the results in different cancer stages and types.

Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer. METHODS: This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691. FINDINGS: Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ2=370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status). INTERPRETATION: Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies. FUNDING: EORTC Quality of Life Group.

Social relationship coping efficacy: A new construct in understanding social support and close personal relationships in persons with cancer.

OBJECTIVE: Social relationship coping efficacy (SRCE) is the confidence to engage in behaviors that can maintain or enhance close social relationships in the context of illness. This study focused on psychometric analyses of the SRCE scale and its role in maintaining or enhancing personal relationships, social support, and quality of life (QOL). METHOD: A mixed diagnosis sample (N = 151) of cancer patients completed a variety of measures: physical debilitation, received emotional and instrumental support, SRCE, and QOL. RESULTS: The SRCE scale is a 10-item, one-factor, internally reliable (α = 0.965) measure with strong concurrent validity in relation to measures of social support. SRCE fully mediated the relationship between physical debilitation and both instrumental and emotional received support. SRCE also was directly related to both social/family well-being and psychological distress, and this relationship was also partially mediated by social support. CONCLUSIONS: The results corroborated that SRCE might account for changes in both instrumental and emotional support. Also, the direct and indirect relationship (mediated by social support) of SRCE with both social/family well-being and distress indicated that interventions to increase SRCE with those at risk for social support loss may bolster social support in personal relationships as well as enhance emotional well-being and quality of life.

Prevalence, characteristics, and treatment of fatigue in oncological cancer patients in Italy: a cross-sectional study of the Italian Network for Supportive Care in Cancer (NICSO).

BACKGROUND: Fatigue is one of the most distressing symptoms of cancer patients. Its characteristics and impact on quality of life have not been fully explored and treatment of cancer-related fatigue in Italian oncological centers has not been codified. METHODS: A cross-sectional study was carried out on all patients attending for any reason the 24 participating centers in two non-consecutive days. Patients with fatigue filled out the Brief Fatigue Inventory (BFI) questionnaire and reported any pharmacological or non-pharmacological treatment for fatigue. RESULTS: From October 2014 to May 2015, 1394 cancer patients agreed to participate in the study. Fatigue was referred by 866 (62.1%) of patients; its duration was > 4 months in 441 patients (50.9%). In the investigators' opinion, the most important (probable or almost sure) determinants of fatigue were reduced physical activity (271 patients), anxiety (149), pain (131), insomnia (125), anemia (123), and depression (123). Fatigue of moderate/severe intensity was reported by 43%/29.2% of patients, while usual fatigue in the last 24 h by 45%/33.1%, and the worst fatigue in the last 24 h by 33%/54.8%, respectively. Concerning the impact on quality of life, fatigue interfered moderately/severely with general activity in 30.8%/38.6% of patients, with mood in 26.1%/32.8%, with the ability to work in 27.9%/35.6%, with normal work in 26.7%/38.9%, with relationships with others in 21%/23.4% and with the ability to amuse themselves in 22.2%/33.1%. Only 117/866 patients (13.5%) received a pharmacological treatment represented by a corticosteroid in 101 patients (86.3%) while 188 patients (21.7%) received a non-pharmacological treatment such as physical exercise (120 patients, 63.8%) and various alimentary supplements (52 patients, 27.6%). CONCLUSIONS: Cancer-related fatigue is frequently reported by oncological patients; its intensity and impact on quality of life is relevant.

Associations between sex, age and spiritual well-being scores on the EORTC QLQ-SWB32 for patients receiving palliative care for cancer: A further analysis of data from an international validation study.

OBJECTIVE: The EORTC QOL Group has recently completed the cross-cultural development and validation of a standalone measure of spiritual well-being (SWB) for cancer patients receiving palliative care: the EORTC QLQ-SWB32. The measure includes four scales: Relationships with Others, Relationship with Self, Relationship with Someone or Something Greater, and Existential, plus a Global-SWB item. This paper reports on further research investigating relationships between sex, age and SWB for patients receiving palliative care for cancer-adjusting for other socio-demographic, clinical and function variables, including WHO performance status and EORTC QLQ-C15-PAL emotional and physical function scores. METHODS: Cross-sectional data from the validation study were used, and chi-square, independent t tests, Mann-Whitney U tests and multiple regression analyses applied. RESULTS: The study included 451 participants with advanced and incurable cancer, from 14 countries. Adjusted analyses found better scores for female participants than males on three of the four EORTC QLQ-SWB32 subscales; Relationship with others, Relationship with Someone or Something Greater and Existential plus Global-SWB. Older age was positively associated with better Relationship with Self. CONCLUSION: The findings from our participants suggest that it might be beneficial if healthcare providers seeking to address patients' spiritual needs pay particular attention to male patients, younger patients and those with poor emotional functioning.

Self-efficacy for coping: utility of the Cancer behavior inventory (Italian) for use in palliative care.

BACKGROUND: Newer models of palliative and supportive cancer care view the person as an active agent in managing physical and psychosocial challenges. Therefore, personal efficacy is an integral part of this model. Due to the lack of instruments in Italian to assess coping self-efficacy, the present study included the translation and validation of the Italian version of the Cancer Behavior Inventory-Brief (CBI-B/I) and an initial analysis of the utility of self-efficacy for coping in an Italian sample of palliative care patients. METHODS: 216 advanced cancer patients who attended palliative care clinics were enrolled. The CBI-B/I was administered along with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Mini Mental Adjustment to Cancer Scale (Mini-MAC), the Cancer Concerns Checklist (CCL), and the Hospital Anxiety and Depression Scale (HADS). The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ratings of functional capacity were completed by physicians. RESULTS: Factor analysis confirmed that the structure of the CBI-B/I was consistent with the English version. Internal consistency reliability and significant correlations with the EORTC QLQ-C30, Mini-MAC, and HADS supported the concurrent validity of the CBI-B/I. Differences in CBI-B/I scores for high versus low levels of the CCL and ECOG-PS supported the clinical utility of the CBI-B/I. CONCLUSIONS: The CBI-B/I has strong psychometric properties and represents an important addition to newer model of palliative and supportive care. In order to improve clinical practice, the CBI-B/I could be useful in identifying specific self-efficacy goals for coping in structured psychosocial interventions.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

BACKROUND: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. METHODS: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. RESULTS: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. CONCLUSIONS: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Phase III study of the European Organisation for Research and Treatment of Cancer Quality of Life cancer survivorship core questionnaire.

PURPOSE: The purpose of this study is to develop a European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) questionnaire that captures the full range of physical, mental, and social health-related quality of life (HRQOL) issues relevant to disease-free cancer survivors. In this phase III study, we pretested the provisional core questionnaire (QLQ-SURV111) and aimed to identify essential and optional scales. METHODS: We pretested the QLQ-SURV111 in 492 cancer survivors from 17 countries with one of 11 cancer diagnoses. We applied the EORTC QLG decision rules and employed factor analysis and item response theory (IRT) analysis to assess and, where necessary, modify the hypothesized questionnaire scales. We calculated correlations between the survivorship scales and the QLQ-C30 summary score and carried out a Delphi survey among healthcare professionals, patient representatives, and cancer researchers to distinguish between essential and optional scales. RESULTS: Fifty-four percent of the sample was male, mean age was 60 years, and, on average, time since completion of treatment was 3.8 years. Eleven items were excluded, resulting in the QLQ-SURV100, with 12 functional and 9 symptom scales, a symptom checklist, 4 single items, and 10 conditional items. The essential survivorship scales consist of 73 items. CONCLUSIONS: The QLQ-SURV100 has been developed to assess comprehensively the HRQOL of disease-free cancer survivors. It includes essential and optional scales and will be validated further in an international phase IV study. IMPLICATIONS FOR CANCER SURVIVORS: The availability of this questionnaire will facilitate a standardized and robust assessment of the HRQOL of disease-free cancer survivors.

Cancer-Related Psychological Distress in Lymphoma Survivor: An Italian Cross-Sectional Study.

Cancer is becoming a chronic disease, and the number of cancer survivors continues to increase. Lymphoma survivors are also increasing in numbers, and anxiety and depression are among the consequences they face. This study aimed to explore psychological distress in a sample of 212 lymphoma survivors. Information through a socio-demographic form and the compilation of questionnaires to assess anxiety, depression, quality of life, and the impact of cancer on lymphoma survivors was collected and analyzed. In the sample examined, 17% of lymphoma survivors were anxiety caseness, and 12.3% were depression caseness, and of these, 8% presented with concomitant anxiety depression. This study identified some variables associated with psychological distress in lymphoma survivors: female sex; living as a couple; a diagnosis of Hodgkin lymphoma; systematic treatment and/or radiotherapy; sleep disorders; no regular physical activity; and present or past use of psychiatric drugs. Our cross-sectional study results suggest that some of the variables investigated may be useful in identifying lymphoma survivors who are more likely to report psychological distress. It is important to monitor psychological distress along the entire trajectory of survivorship in order to identify early the presence of anxiety and depression and to provide timely psychological support.

The Role of the Psycho-Oncologist during the COVID-19 Pandemic: A Clinical Breast Cancer Case Report.

The 2019 coronavirus pandemic (COVID-19) has been very stressful, but more so for those with cancer. Patients with cancer experienced more pandemic-related stress and psychological distress than those without a cancer diagnosis. This case report, about a breast cancer patient, is presented in order to emphasize (1) the importance of the management of psychological care in oncology, (2) the need for a thorough understanding of the efficacy of the role of the psycho-oncologist and related interventions in a breast care unit for the health of both patients and professionals to improve clinical outcomes, and (3) the emerging health concerns of breast cancer patients in the context of the COVID-19 pandemic.

Mindfulness Meditation as Psychosocial Support in the Breast Cancer Experience: A Case Report.

In the last decade, Mindfulness-based interventions have been increasingly used in health care settings, particularly in the context of cancer. Research documents the efficacy of these interventions for decreasing the burdens of stress, anxiety, depression, fatigue, sleep disorders, and other symptoms. This article describes the case report of a patient with breast cancer, highlighting her personality, defense mechanisms, and traumatization connected with the disease. General information about the patient's personal and medical history is presented in addition to the trajectory of psychoncological support, focusing on objectives, intervention strategies based on Mindfulness, and outcomes. The intervention is a combination of individual and group therapies, with particular reference to the use of Mindfulness in a group setting. The goal is to provide the patient with both a peer sharing experience as well as the tools to manage psychoemotional reactions through the development of awareness and a better relationship with herself. The main hypothesized consequences are an increase in self-esteem and coping strategies, which are necessary for a successful adaptation to cancer. The objective of the Mindfulness intervention is to promote the maintenance of an adequate Quality of Life (QoL) and psychological well-being, during and after treatment, transferring these skills into daily life.

COVID-19 pandemic distress among a sample of Italian psycho-oncologists: risk of isolation and loneliness.

PURPOSE: To measure the prevalence and characteristics of distress and hope for the future among psycho-oncologists, who faced the coronavirus disease 2019 (COVID-19) emergency along with other healthcare workers. METHODS: A web-based study was conducted among members of the Italian Society of Psycho-Oncology between May 29 and June 5, 2020. RESULTS: A total of 237 members, aged 28-72 years, completed the COVID-19 Peritraumatic Distress Index (CPDI), Impact of Event Scale-Revised (IES-R), and HOPE questionnaires; 86.92% were female, 58.65% worked in hospitals, 21.10% were exposed to COVID-19, 11.39% experienced peritraumatic distress, and 3.38% had posttraumatic stress disorder symptoms. Peritraumatic distress was associated with living alone (adjusted odds ratio [AOR] 3.05; 95% confidence interval [CI] 1.41-8.13), using sleep remedies (AOR 3.79; 95% CI 1.41-10.21), and the perception of being avoided by family or friends because of work (AOR 2.69; 95% CI 1.02-7.11); high HOPE-Agency scores were associated with the absence of peritraumatic stress (AOR 0.40; 95% CI 0.16-0.96) after adjustment for age and sex. CONCLUSIONS: Psycho-oncologists showed greater resilience than other healthcare workers as they are trained to help others, but also to review their own values and behavior in light of stressful events. Of interest is the association between peritraumatic distress and social isolation, real or perceived. Healthcare institutions should pay attention to the mental well-being of their employees by promoting distress screening using simple tools such as the CPDI and implementing support interventions. Psycho-oncology associations should introduce policies aimed at developing a sense of social connectedness by providing an interactive system of orientation and scientific reference.

Assessment of socio-relational self-efficacy in breast cancer patients: Italian validation of the social relationship coping efficacy scale (SRCE-I).

BACKGROUND: Social relationship coping efficacy (SRCE) represents the ability to maintain or enhance social relationships in the context of serious illness. The purpose of the current study was to confirm the factor structure, psychometric properties, and utility of the Italian version of the SRCE scale. METHODS: 181 breast cancer patients completed the SRCE-Italian (SRCE-I), the Cancer Behavior Inventory-Brief/Italian (CBI-B/I), quality of life (QOL) measures (EORTC QLQ-C30; EORTC QLQ-BR23), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: The SRCE-I was internally consistent (Cronbach alpha = .95) and factor analysis confirmed that the SRCE-I was a unidimensional construct. In terms of validity, the SRCE-I was correlated with QOL (EORTC QLQ-30, Social Functioning, r = .33, Emotional Functioning, r = .57, and Global Health/Quality of Life; r = .54) and scales of the EORTC QLQ-BR23 (e.g., Future Perspective, r = .38; Breast Symptoms, -.31). SRCE-I was also correlated negatively with the HADS (r = -.72) and positively with the CBI-B/I (r = .79), a measure of coping efficacy (all ps < .001). Mediation analyses confirmed the utility of the SRCE-I scale as a mediating mechanism in enhancing social functioning and QOL. CONCLUSIONS: The SRCE-I is a structurally sound, reliable, and valid measure that assesses the ability to maintain or enhance social support and mitigate the loss of social support. The SRCE-I can be used as a screening measure to assess low efficacy for maintaining social support or as a measure to detect the change in efficacy for enhancing social support in interventions to improve the QOL of patients.

Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study.

OBJECTIVE: To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer. BACKGROUND: Little evidence is available on PROs after pCRT for rectal cancer. PATIENTS AND METHODS: Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (t0), 2 to 3 weeks after completion of CRT (t1), and at 6 (t2) and 12 months (t3) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems. RESULTS: Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t0, t1, t2, and t3, respectively. At t3, 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment. CONCLUSIONS: These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions.

Psychological well-being outcomes in disease-free survivors of mid-low rectal cancer following curative surgery.

OBJECTIVE: The aim of this cross-sectional study was to evaluate psychological well-being outcomes in disease-free survivors who previously underwent radical surgery for rectal adenocarcinoma. METHODS: All patients with rectal adenocarcinoma who underwent primary surgery at a single institution from 1990 to 2002 were considered for inclusion in the study. We identified and sent questionnaires to 145 patients after excluding those who had died or had recurrent disease. One hundred and seventeen patients (men/women: 74/43; median age: 65 years) returned the questionnaires. Patients' well being was evaluated using the Psychological General Well-Being Index (PGWBI) questionnaire. The mean PGWBI score was compared with normative data of the general population. The impact of patient-, tumor- and treatment-related factors on patients' long-term psychological well-being status was also evaluated. RESULTS: Compared with the general population, study patients had significantly better anxiety, depressed mood, positive well being, general health, vitality scales and global index scores. On multivariate analysis, positive well being was independently affected by time from diagnosis (36 months; p=0.025) and occurrence of early major complications (p=0.024). Variables that were independently associated with worse self-control included primary education (p=0.04) and the presence of fecal urgency (p=0.049). General health was negatively affected by time from diagnosis (36 months; p=0.047) and fecal urgency (p=0.009). CONCLUSIONS: Patients who have survived cancer are likely to re-evaluate the importance of everyday events and this may explain why they had better PGWBI scores. This study also identified that a short time from diagnosis, early adverse events and bowel dysfunction had a negative impact on patients' well being.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Health-related quality of life, faecal continence and bowel function in rectal cancer patients after chemoradiotherapy followed by radical surgery.

PURPOSE: To evaluate health-related quality of life (HRQOL), faecal continence and bowel function of patients with rectal cancer who underwent preoperative chemoradiotherapy (pCRT) in a cross-sectional setting. METHODS: Out of 185 consecutive patients who underwent pCRT for rectal cancer from 1994 to 2004 at a single institution, 101 were eligible for the study. Causes of exclusion were: death (n = 38), not radical surgery or recurrence (n = 21), presence of stoma at the time of the survey (n = 15), lost to follow-up (n = 6) and miscellaneous (n = 4). Eligible patients were asked to complete: the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, the disease specific colorectal module (EORTC QLQ-CR38) and faecal incontinence and bowel function questionnaires. HRQOL outcomes were compared with reference data from the general population, and the association among clinical variables and HRQOL was also investigated with linear regression analyses. RESULTS: Questionnaires were completed by 80% of eligible patients. Compared to population-based norms, patients showed clinically meaningful worse outcomes in terms of constipation and diarrhoea. Stool fractionation (p < 0.01) and use of enema/laxative (p < 0.01) were negatively associated with global health status/QOL. Urgency negatively affected physical (p < 0.01), role (p < 0.01) and social functioning (p < 0.01). Sensation of incomplete evacuation negatively affected social functioning (p < 0.01). CONCLUSIONS: Although HRQOL profile of these patients is broadly similar to that of healthy subjects, there are still important limitations in terms of key symptoms. The use of validated questionnaires is crucial to provide standardised information on relevant health status areas.