Vaginal changes, sexual functioning and distress of women with locally advanced cervical cancer treated in the EMBRACE vaginal morbidity substudy.

OBJECTIVE: The EMBRACE-vaginal morbidity substudy prospectively evaluated physician-assessed vaginal changes and patient-reported-outcomes (PRO) on vaginal and sexual functioning problems and distress in the first 2-years after image-guided radio(chemo)therapy and brachytherapy for locally advanced cervical cancer. METHODS: Eligible patients had stage IB1-IIIB cervical cancer with ≤5 mm vaginal involvement. Assessment of vaginal changes was graded using CTCAE. PRO were assessed using validated Quality-of-Life and sexual questionnaires. Statistical analysis included Generalized-Linear-Mixed-Models and Spearman's rho-correlation coefficients. RESULTS: 113 eligible patients were included. Mostly mild (grade 1) vaginal changes were reported over time in about 20% (range 11-37%). At 2-years, 47% was not sexually active. Approximately 50% of the sexually active women reported any vaginal and sexual functioning problems and distress over time; more substantial vaginal and sexual problems and distress were reported by up to 14%, 20% and 8%, respectively. Physician-assessed vaginal changes and PRO sexual satisfaction differed significantly (p ≤ .05) between baseline and first follow-up, without further significant changes over time. No or only small associations between physician-assessed vaginal changes and PRO vaginal functioning problems and sexual distress were found. CONCLUSIONS: Mild vaginal changes were reported after image-guided radio(chemo)therapy and brachytherapy, potentially due to the combination of tumors with limited vaginal involvement, EMBRACE-specific treatment optimization and rehabilitation recommendations. Although vaginal and sexual functioning problems and sexual distress were frequently reported, the rate of substantial problems and distress was low. The lack of association between vaginal changes, vaginal functioning problems and sexual distress shows that sexual functioning is more complex than vaginal morbidity alone.

The silent transition from curative to palliative treatment: a qualitative study about cancer patients' perceptions of end-of-life discussions with oncologists.

OBJECTIVE: The aims of the study were to examine patients' experiences of end-of-life (EOL) discussions and to shed light on patients' perceptions of the transition from curative to palliative care. METHODS: This study was based on a qualitative methodology; we conducted semi-structured interviews with advanced cancer patients admitted to the palliative care unit (PCU) of the Medical University of Vienna. Interviews were recorded digitally and transcribed verbatim. Data were analyzed based on thematic analysis, using the MAXQDA software. RESULTS: Twelve interviews were conducted with patients living with terminal cancer who were no longer under curative treatment. The findings revealed three themes: (1) that the medical EOL conversation contributed to the transition process from curative to palliative care, (2) that patients' information preferences were ambivalent and modulated by defense mechanisms, and (3) that the realization and integration of medical EOL conversations into the individual's personal frame of reference is a process that needs effort and information from different sources coming together. CONCLUSIONS: The results of the present study offer insight into how patients experienced their transition from curative to palliative care and into how EOL discussions are only one element within the disease trajectory. Many patients struggle with their situations. Therefore, more emphasis should be put on repeated offers to have EOL conversations and on early integration of aspects of palliative care into the overall treatment.

Hope as determinant for psychiatric morbidity in family caregivers of advanced cancer patients.

OBJECTIVE: Home care of advanced cancer patients often has adverse effects on physical and mental health of family caregivers. Little is known about the long-term effects of continuous caregiving on mental health as compared with the effects of bereavement. The objectives of this study were to describe the course of psychiatric morbidity in family caregivers over time, to identify the impact of the patients' death on caregivers, and to explore possible predictor variables for psychiatric morbidity. METHODS: This multi-institutional, prospective study included 80 family caregivers of 80 advanced cancer patients for baseline and 9 months follow-up assessment. Possible psychiatric disorders (ie, depression, anxiety, posttraumatic stress disorder, and alcohol abuse/dependence) as well as potentially predictive factors (ie, sociodemographic factors, burden, hope, and coping mechanisms) were assessed. RESULTS: Follow-up assessment was conducted on average 9.2 months (±2.9) after baseline assessment. Prevalence rates of anxiety and posttraumatic stress disorder decreased significantly over time, whereas depression and alcoholism remained stable. Bereavement was experienced by 53% of caregivers in the follow-up period. The patients' death had no influence on psychiatric morbidity at follow-up. Predictors for the development of a psychiatric disorder varied according to condition, with hope and emotion-oriented coping identified as important influences, especially for anxiety and depression. CONCLUSION: Family caregivers with certain psychiatric disorders might need targeted psychosocial support to ensure their mental well-being and prevent long-term disability. Supporting hope and functional coping strategies early after the patient's diagnosis might limit development and extent of psychiatric morbidity.

Informal caregivers of advanced-stage cancer patients: Every second is at risk for psychiatric morbidity.

PURPOSE: Informal caregivers of advanced cancer patients are known to suffer from high distress due to their caregiving responsibilities. Nevertheless, a comprehensive evaluation of psychiatric morbidity is often missing in clinical practice due to time resources, and mental health problems may be unnoticed in this population. A feasible approach is needed to identify caregivers at risk for psychiatric disorders to offer targeted interventions and enhance their well-being. METHODS: This cross-sectional, multi-institutional study screened 345 caregivers of advanced cancer patients for psychiatric disorders (i.e., depression, anxiety, posttraumatic stress disorder, and alcohol abuse/dependence) and assessed factors potentially associated with mental health diagnoses (including socio-demographic factors, burden, hope, caring-related quality of life, and coping preferences). RESULTS: Overall, almost 52 % of participants had one or more suspected psychiatric disorders, with anxiety being the most prevalent. Perceived hope, higher burden, and more emotion-oriented coping were associated with psychiatric morbidity in this sample. Spouses and parents showed significantly more symptoms of psychiatric disorders than other relatives. CONCLUSIONS: This study confirms the high risk of informal caregivers of advanced cancer patients to develop psychiatric disorders and suggests a practically feasible approach to identify at risk caregivers to offer support.

Distant metastasis in patients with cervical cancer after primary radiotherapy with or without chemotherapy and image guided adaptive brachytherapy.

OBJECTIVE: The aim of this study is to investigate patterns of distant relapse after primary radiochemotherapy in cervical cancer patients. METHODS: All patients with cervical cancer treated in curative intent with external beam radiotherapy +/- chemotherapy and image-guided adaptive brachytherapy between January 1998 and June 2009 at the Medical University of Vienna were included in this retrospective analysis. Patients with locoregional recurrences were excluded from this study. Presence, site of and time to distant metastases were recorded. For identifying prognostic factors, uni- and multivariate analyses using Cox regression analysis were performed. Based on the result from the multivariate analysis, patients were stratified into a high and a low risk group. The Kaplan-Meier method was used to estimate distant-metastasis-free-survival in the overall cohort, in the risk groups and for analysing the impact of chemotherapy within the risk groups. RESULTS: A total number of 189 patients were included in this study. After a median follow-up of 54 months, 49 patients developed distant metastases. Overall, distant-metastasis-free-survival 5 years after treatment was 73%. FIGO stage, lymph node status and the extent of tumour regression during treatment were significant predictors for distant metastasis. Distant-metastasis-free-survival 5 years after treatment was 91% and 60% in the low and high risk groups, respectively. The number of the cycles of chemotherapy had a significant impact on the occurrence of distant metastasis in high risk patients, but not in low risk patients. CONCLUSION: Patients with high risk factors have a 40% probability of developing distant metastasis within 5 years. In these patients, decreasing the number of cycles of cisplatin may increase their probability of developing distant metastasis.

Validation and practical implementation of a multidisciplinary cancer distress screening questionnaire.

BACKGROUND: In order to identify cancer patients with psychosocial needs during radiotherapy, a routine screening questionnaire is widely recommended in the literature. Several tools focusing mainly on psychological issues have been developed during the past decade. However, problems with their implementation into clinical routine have been repeatedly reported, due to a lack of practicability for clinicians and nurses. This study reports the compilation of a multidisciplinary screening questionnaire and an analysis of the effectiveness of its implementation into clinical routine at the Department of Radiotherapy, Medical University of Vienna. MATERIALS AND METHODS: The screening questionnaire is based on a compilation of several subscales from established and validated assessment tools. It focuses on comprehensive information with high a clinical relevance for all professions. In a pilot study, patients' acceptance was assessed qualitatively. Analysis of missing screening data in consecutively admitted patients reflects the effectiveness of implementation and representativity of the data. A validation analysis of the psychological subscales was performed using external criteria and its internal consistency was tested with Cronbachs' α. RESULTS: Qualitative patient acceptance of the screening questionnaire is good. The overall response rate in the screening procedure was 75 %. Missing patient screening data sets arose randomly-mainly due to organizational problems-and did not result in systematic errors. The psychological subscales identify highly distressed patients with a sensitivity of 89 and 78 %, and an internal consistency of 0.843 and 0.617. CONCLUSION: The multidisciplinary screening questionnaire compiled in this study has a high patient acceptance, provides reliable and representative data and identifies highly distressed patients with excellent sensitivity. Although requiring additional personnel resources, it can be implemented successfully in clinical routine with benefits for both the patient and the professional team.

Physical and psychosocial support requirements of 1,500 patients starting radiotherapy.

BACKGROUND: The need for psychosocial support in cancer patients is estimated in the literature at 14-50 %. At the Department of Radiation Oncology, Medical University of Vienna, approximately 3,000 patients are seen annually. Due to limited staff resources, highly distressed patients need to be selected for focused support. A multidisciplinary screening questionnaire covering physical, social and psychological problems and needs was successfully implemented in clinical routine. We present the results of a representative sample of 1,500 heterogeneous cancer patients before beginning radiotherapy. PATIENTS AND METHODS: The prevalence rates of physical, social and psychological problems and needs were evaluated. Independent risk factors for critical psychological distress were analyzed in a multivariate logistic regression model, in order to identify vulnerable subgroups for focused psychosocial support. RESULTS: Critical psychological distress was found in 22 % of the overall cohort, of whom only 26 % reported a need for psychological information. Clinically relevant pain was suffered by 31 %. Patients' most frequent complaints were weakness, sleeping difficulties and exhaustion. Consequently, 40 % were impaired in activities and 35 % reported a requirement for support in daily life. A need for further information was expressed by 37 % of patients. Significant risk factors for critical psychological distress included pain, functional status, support requirements and patient-reported symptoms. Differences in tumor type, metastases and sociodemographic variables had no impact on critical psychological distress. CONCLUSION: Approximately one third of all patients beginning radiotherapy have physical, social and psychological problems and should receive focused psychosocial support. Multivariate analysis reveals that patients with impaired "physical integrity" are at a significantly higher risk of experiencing critical psychological distress.

Feasibility of transrectal ultrasonography for assessment of cervical cancer.

PURPOSE: To retrospectively compare the maximum target width and target thickness in patients with locally advanced cervical cancer between magnetic resonance imaging (MRI) and transrectal ultrasonography (TRUS) in the course of primary radiochemotherapy. PATIENTS AND METHODS: T2-weighted MRI and TRUS were performed on patients with locally advanced cervical cancer at the same timepoint-either at the time of diagnosis, or at the time of brachytherapy before or after insertion of the applicator. Patients treated from 2009 to 2011 were selected for this study based on the availability of MRI and TRUS at the defined time points. The target was defined as the complete macroscopic tumor mass and the remaining cervix and was measured on transversal planes. Descriptive statistics and a linear regression analysis were performed for the groups. RESULTS: Images from 17 patients were available for analysis. Mean maximum target width was 4.2 ± 0.83 cm and 4.2 ± 0.79 cm for MRI and TRUS, respectively. Mean maximum target thickness was 3.3 ± 1.03 cm and 3.1 ± 1.15 cm for MRI and TRUS, respectively. Linear regression analysis for target width and thickness between TRUS and MRI demonstrated a correlation with R(2) = 0.842 and R(2) = 0.943, respectively. CONCLUSION: The feasibility of TRUS for the assessment of local target extension could be demonstrated. Comparison of the target width and thickness showed a high correlation between TRUS and MRI, indicating the potential of TRUS for target definition in image-guided adaptive brachytherapy.

Radiation-induced morphological changes in the vagina.

BACKGROUND AND PURPOSE: Treatment-induced chronic vaginal changes after definitive radio(chemo)therapy for locally advanced cervical cancer patients are reported as one of the most distressing consequences of treatment, with major impact on quality of life. Although these vaginal changes are regularly documented during gynecological follow-up examinations, the classic radiation morbidity grading scales are not concise in their reporting. The aim of the study was therefore to identify and qualitatively describe, on the basis of vaginoscopies, morphological changes in the vagina after definitive radio(chemo)therapy and to establish a classification system for their detailed and reproducible documentation. PATIENTS AND METHODS: Vaginoscopy with photodocumentation was performed prospectively in 22 patients with locally advanced cervical cancer after definitive radio(chemo)therapy at 3-24 months after end of treatment. All patients were in complete remission and without severe grade 3/4 morbidity outside the vagina. RESULTS: Five morphological parameters, which occurred consistently after treatment, were identified: mucosal pallor, telangiectasia, fragility of the vaginal wall, ulceration, and adhesions/occlusion. The symptoms in general were observed at different time points in individual patients; their quality was independent of the time of assessment. Based on the morphological findings, a comprehensive descriptive and semiquantitative scoring system was developed, which allows for classification of vaginal changes. A photographic atlas to illustrate the morphology of the alterations is presented. CONCLUSION: Vaginoscopy is an easily applicable, informative, and well-tolerated procedure for the objective assessment of morphological vaginal changes after radio(chemo)therapy and provides comprehensive and detailed information. This allows for precise classification of the severity of individual changes.

Do clinicians and patients agree regarding symptoms? A comparison after definitive radiochemotherapy in 223 uterine cervical cancer patients.

BACKGROUND: In clinical cancer research of morbidity, low associations between clinician-assessed toxicity/morbidity and patient-reported symptoms are consistently described in the literature. While morbidity grading systems are supposed to follow more or less objective criteria, patient reported symptoms inherently are based on a subjective self-evaluation of the impact on quality of life. The aim of this study was to focus on major discrepancies with high clinical relevance and to evaluate its impact with regard to underreporting of morbidity. MATERIAL AND METHODS: Early morbidity assessed by clinicians with CTCAEv.3 and patient reported quality of life (EORTC-QLQ-C30/CX24) were compared regarding 12 overlapping symptoms in 223 patients with uterine cervical cancer 3 months after definitive radio(chemo)therapy in the ongoing EMBRACE study. Mismatches showing discrepancies between both grading systems were classified, if patients reported substantial symptoms (quite a bit/very much) and CTCAE grading was rated G0. RESULTS: In total, 360 substantial symptoms were reported by patients by EORTC-QLQ; 159 (44%) of those were not recognized by CTCAE. Symptoms with the highest occurrence of mismatches overall are urinary frequency, fatigue, and insomnia. Large institutional differences were found, showing two centers with 4 vs. 71% of patients with at least one mismatch. CONCLUSION: Analysis of mismatches indicated a high risk of underestimation of early morbidity. Thus, nearly half of the patient-reported substantial symptoms were not recognized by CTCAE scoring (G0) 3 months after treatment. Prospective assessment of morbidity in clinical studies should, therefore, integrate patient reported symptoms to receive a complete and comprehensive picture.