Locus of control and distressing symptoms in young cancer patients when assessing depression.

PURPOSE: The aim of the current study was to evaluate the correlation between depression, sense of control (internal and external) and cancer-related distressing symptoms in younger patients (<65 years) with locally advanced or metastatic cancer, and to investigate their potential predictive role when screening for depression. METHODS: 70 patients completed the Beck Depression Inventory (BDI), the Cancer Locus of Control Scale, the Linear Analogue System Assessment (LASA) (for Quality of Life/ QoL) and the M.D. Anderson Symptom Inventory (MDASI). Distressing symptoms, QoL, and locus of control (LOC) were correlated with the presence of depression. RESULTS: The total BDI score was suggestive of depression. In univariate analysis significant correlations were found between the presence of depression and poor QoL, low Eastern Cooperative Oncology Group performance status and 'sense of control over the course of cancer' (p<0.0005). Depression was significantly correlated with pain, distress and poor general activity, overall enjoyment of life and relationships (p=0.004), as well as anxiety, fatigue, anorexia, dyspnoea and sleep disturbances (p=0.001). Multivariate analysis demonstrated that poor QoL and 'sense of control over the course of cancer', as well as anxiety, fatigue, anorexia, dyspnoea and sleep disturbances were significantly correlated with depression (p<0.0005). CONCLUSIONS: We suggest that younger cancer patients' poor QoL, 'sense of control over the course of cancer', as well as anxiety, fatigue, anorexia, dyspnoea and sleep disturbances are significantly correlated with the presence of depression and can eventually represent potential screening predictors.

The influence of distressing symptoms to levels of depression in cancer patients.

PURPOSE: Our objectives were to identify the depression and the distressing symptoms in younger and elderly advanced cancer patients. METHODS: : The instruments that have been used were the Beck Depression Inventory (BDI) for younger patients, the Geriatric Depression Scale (GDS) for geriatric patients and the M. D. Anderson Symptom Inventory (MDASI) for the severity and impact of cancer-related symptoms. RESULTS: A trend for significant correlation was found between the GDS and MDASI symptoms for nausea (p=0.058), while a significant correlation was observed for increased sadness (p=0.011), increased constipation (p=0.021), interference of symptoms in mood (p=0.012) and in relations with people (p=0.007); interference of symptoms in mood was the most important risk factor. For younger patients, many statistically significant associations were found between distressing symptoms and depression; however, interference of symptoms in mood (p=0.045) was the only important risk factor. CONCLUSION: Health-care professionals should take into consideration the risk factors for depressive symptoms suggesting a holistic care in advanced cancer patients.

Caregivers' anxiety and self-efficacy in palliative care.

This study examined the relationship between caregivers' anxiety supporting a patient with advanced cancer and self-efficacy and their socio-demographic characteristics, and then whether these variables could influence their self-efficacy. One hundred and seven caregivers of advanced cancer patients participated in the study and completed the Greek versions of the State-Trait Anxiety Inventory (STAI) and the General Perceived Self-efficacy Scale (GSE). Significant comparisons were found between State anxiety and female gender (P= 0.009), cohabitation (P= 0.002) and relationship with the patient (P= 0.004); statistically significant associations were found between State, Trait anxiety and self-efficacy scores of caregivers (P < 0.0005 respectively). A multiple regression model (enter method) showed women (P= 0.005), spouses (P= 0.01) and self-efficacy (P= 0.02) as the significant predictors of State anxiety. Furthermore, self-efficacy seemed to be the strongest contributor of trait anxiety (P < 0.0005). Female caregivers and spouses of advanced cancer patients experience more state anxiety levels than men and other caregivers respectively. In addition, caregivers with low self-efficacy are more likely to have elevated anxiety scores than self-efficacious caregivers. These findings can help healthcare professionals focus on some problems common to caregivers of cancer patients and plan appropriate interventions.

Posttraumatic stress disorder and preparatory grief in advanced cancer.

PURPOSE: The purpose of the current study was to investigate the prevalence of posttraumatic stress disorder (PTSD) and its association with sociodemographic variables and preparatory grief in patients with advanced cancer. METHODS: 195 advanced cancer patients participated in the study. Out of them, 170 had PTSD and 25 had other anxiety disorders. The diagnoses were made in strict accordance with Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I)-Clinician version. Patients completed also the Preparatory Grief in Advanced Cancer Patients (PGAC) scale. RESULTS: Patients with PTSD were younger (63.54 ± 12.07 years) than those without PTSD (70.36 ± 13.03 years, p=0.010). Patients with PTSD revealed more preparatory grief (37.69 ± 12.11) than those without PTSD (29.58 ± 14.04, p= 0.003). Multiple logistic regression analysis showed that preparatory grief (p=0.012), and metastatic disease (p=0.009) remained in the model whereas age showed a trend for independent significance (p=0.067). CONCLUSION: In advanced cancer stages, younger patients, those with metastatic disease or patients with elevated scores on preparatory grief seemed to have a greater likelihood to develop PTSD. Thus, given the prevalence of PTSD in advanced cancer patients, health care professionals should be able to better recognize those who are at risk for or exhibit symptoms of this disorder so that appropriate treatment referrals can be made.

Differences in levels of self-efficacy and anxiety between cancer and chronically-ill patients attending a Palliative Care Unit.

PURPOSE: To investigate the differences in anxiety and self-efficacy beliefs as well as the sociodemographic and clinical characteristics, between cancer and chronically-ill patients. METHODS: A total of 175 patients from a pain relief and palliative care unit participated in this study. Patient sociode-mographic and clinical characteristics were recorded. Patients completed the Greek version of the Spielberger State-Trait Anxiety Inventory (STAI) and the Greek version of the General Perceived Self-Efficacy Scale (GSE). RESULTS: No statistically significant differences were found between the two patient populations regarding self-efficacy. Statistically significant differences were found between chronically-ill and cancer patients in the scales of "emotionality" (p<0.0005), and "self-deprecation" (p<0.0005). Statistically significant negative correlations were found between all STAI scales and self-efficacy for both cancer and chronically-ill patients (r ranged from -0.231 to -0.503). CONCLUSION: Chronically-ill patients experienced increased anxiety compared to cancer patients. Self-efficacy had a significant negative correlation with anxiety between the two groups of patients.

Self-efficacy beliefs and levels of anxiety in advanced cancer patients.

The aims of this study were to investigate the self-efficacy and anxiety in advanced cancer patients in a palliative care unit. The subject is some 99 advanced cancer patients, treated for pain relief and cancer-related symptoms. Patients completed the General Perceived Self-Efficacy Scale (GSE) and the Spielberger's State-Trait Anxiety Inventory (STAI). The Eastern Cooperative Oncology Group was used to measure patients' performance status. Statistically significant associations were found between GSE, patients' gender, performance status, opioids and all the STAI scales. The multiple regression analysis revealed that self-efficacy was predicted by patients' age, performance status, gender, as well as by their high levels on two STAI scales, in a model explaining 39.7% of the total variance. In advanced cancer patients, self-efficacy is significantly correlated with levels of anxiety, patients' physical condition and demographic characteristics. Also, it seems to be influenced by components of the STAI, patients' age, physical performance and gender.

How is sleep quality affected by the psychological and symptom distress of advanced cancer patients?

The aim of this study was to assess the relationship between sleep quality, pain, psychological distress, cognitive status and post-traumatic experience in advanced cancer patients. Participants were 82 advanced cancer patients referred to a palliative care unit for control of pain and other symptoms. A variety of assessment tools were used to examine the prevalence of sleep disturbance, the severity of pain and depression, hopelessness, cognitive function and quality of life. Using the Pittsburgh Sleep Quality Index (PSQI) 96% of patients were 'poor sleepers'. Statistically significant associations were found between PSQI and the SF-12 (Short Form-12) Quality of Life Instrument (MCS, P < 0.0005, PCS, P < 0.0005), depression (Greek Depression Inventory) (P < 0.0005) and hopelessness (Beck Hopelessness Scale) (P = 0.003). Strong associations were also found between PSQI and IES-R (Impact of Event Scale-Revised) (P = 0.004). The strongest predictors of poor sleep quality in this model were MCS (P < 0.0005), PCS (P < 0.0005) and IES-R (P = 0.010). Post-traumatic experience and quality of life seemed to be the strongest predictors of sleep quality in a sample of advanced cancer patients referred for palliative care.

Ethical and Practical Challenges in Implementing Informed Consent in HIV/AIDS Clinical Trials in Developing or Resource-Limited Countries

Background/rationale: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. Objectives: The major objective was to address informed consent in human research in non-Western societies; and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations; such as children; adolescents and women. Methods: A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed; using the search terms `HIV/AIDS'; `informed consent'; `clinical trials'; `developing world'. Results: Ethical complexities such as participants' diminished autonomy; coercion or monetary inducement; language difficulties; illiteracy or lack of true understanding of the entire study; cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age; while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used; while trusted community leaders and local cultural representatives may convey information. Discussion: Despite the heterogeneity of studies; similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representation. Conclusions: International investigators of HIV human research should bear in mind these ethical issues and their potential solutions; when trying to ensure ethical research conduct; based on a truly informed and culturally relevant consent

Preparatory grief, psychological distress and hopelessness in advanced cancer patients.

A study was undertaken to evaluate the preparatory grief process in advanced cancer patients and its relationship with hopelessness, depression and anxiety. In total, 94 advanced cancer patients treated in a Pain Relief and Palliative Care Unit completed the Preparatory Grief in Advanced Cancer Patients (PGAC) Scale, the Greek Hospital Anxiety and Depression (G-HAD) scales, and a measure of hopelessness the Beck Hopelessness Scale. The strongest correlation was found between grief and hopelessness (r = 0.63, P < 0.0005) and PGAC-1 'self-consciousness' (r = 0.54, P < 0.0005). Similarly, strong associations revealed between PGAC total with anxiety (HAD-D) and depression (HAD-D) (P < 0.0005). Significant associations were depicted between hopelessness, depression and anxiety with PGAC-total as well as with its components. Statistically significant associations were also obtained between grief, metastases (P = 0.073) and education (P = 0.043). In the multiple regression analysis (enter method), anxiety (P < 0.0005) was the strongest predictor of preparatory grief followed by hopelessness (P = 0.002), presence of metastases (P = 0.004) and depression (P = 0.033). Depression, hopelessness, anxiety and terminally ill patients' metastases contribute to the prediction of preparatory grief in this population.

Beck Depression Inventory: exploring its psychometric properties in a palliative care population of advanced cancer patients.

To validate the Greek version of the Beck Depression Inventory (BDI)-21 items in advanced cancer patents attending a palliative care unit. The scale was translated with the forward-backward procedure into Greek. It was administered twice, with a 1-week interval, to 105 patients with advanced cancer. The patients also completed the Hospital Anxiety and Depression (HAD) scale, while researchers recorded data on demographic characteristics, disease status and treatment regimen. The Greek version of the BDI had overall Cronbach's alpha 0.906. The most significant correlations were found between BDI and performance status (P < 0.0005), gender (P = 0.031) and family status (P = 0.009). The test-retest reliability in terms of Spearman-rho, Pearson-rho coefficient and Kendall's tau-b was also satisfactory (P < 0.0005). Validity as performed using known-group analysis showed good results. The Inventory discriminated well between subgroups of patients differing in disease severity as defined by the Eastern Cooperative Oncology Group performance status. Correlations between the BDI and the HAD scale was 0.544 for the anxiety subscale and 0.657 for the depression subscale. Multiple regression analysis was conducted and predicted that the contribution of gender, family status and performance status to BDI is high. These psychometric properties of the Greek version of the BDI confirm it as a valid and reliable measure when administered to patients with advanced cancer.

Prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy to moderate or high emetogenic areas: a prospective randomized open label study in cancer patients.

AIM: A prospective randomized open label study was carried out to evaluate the efficacy and effectiveness of prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy. PATIENTS AND METHODS: The study sample consisted of 288 cancer patients randomly allocated (3:4 ratio) into two treatment groups: 120 patients received prophylactic antiemetic treatment with tropisetron and 168 patients received rescue tropisetron. To determine the efficacy of prophylactic antiemetic treatment, nausea and vomiting were evaluated 1 d before radiation therapy (RT), at 24 and 72 h, at the end of every week during RT, and finally 1 wk after RT. Diary cards were used to record the intensity of nausea and vomiting as well as the incidence of adverse effects. RESULTS: In the odds of nausea and vomiting, statistically significant differences were found between the two treatment groups over time. The incidence of nausea and vomiting were 1.89 (p = 0.009) and 2.19 (p = 0.001) times higher in the rescue tropisetron group than in the prophylactic tropisetron group. Factors that related significantly with increased nausea were primary cancer, rescue tropisetron, and radical RT. Moreover, factors for vomiting were primary cancer type, metastasis, palliative RT, and rescue tropisetron. CONCLUSIONS: Higher numbers of patients receiving prophylactic tropisetron completed RT with lower incidence of nausea and vomiting than those in the rescue tropisetron group.

Assessment of anxiety and depression in advanced cancer patients and their relationship with quality of life.

The growing interest in the mental health and quality of life of cancer patients, has been the major reason for conducting this study. The aims were to compare advanced cancer patients' responses to Hospital Anxiety and Depression (HAD) scale with those to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0), as well as the impact of quality of life dimensions (as measured by EORTC QLQ-C30) on the levels of anxiety and depression. The analysis, conducted in 120 advanced cancer patients, showed that the most significant associations were found between emotional functioning and HAD-T (total sum of scores) (r=-0.747; p < 0.0005), HAD-A (anxiety) (r=-0.725; p < 0.0005) and HAD-D (depression) (r=-0.553; p < 0.0005). In the prediction of HAD-T, the contribution of physical, emotional, role, and social functioning along with nausea-vomiting, dyspnea, sleep disturbance and gender is high. For anxiety, the predictor variables were physical, role, cognitive, emotional, and social functioning, followed by dyspnea, sleep disturbance, and appetite loss, while depression was predicted by physical, role, emotional, and social functioning, the symptoms of nausea-vomiting, pain, sleep disturbance, constipation, as well as the variables of age, gender, anticancer treatment and performance status. Concluding, psychological morbidity, in this patient population, was predominantly predicted by the emotional functioning dimension of EORTC QLQ-C30.

Patterns and barriers in information disclosure between health care professionals and relatives with cancer patients in Greek society.

The issue of whether, how and how much to tell cancer patients concerning diagnosis is still approached in various ways across different countries and cultures. The health care team-patient relationship is a triangle consisting of the health care professionals, the patient and the family. Each part supports the other two and is affected by the changes that happen in the triangle. The objective of the study was to investigate the communication context through which health care professionals and families with cancer patients interact. In Greece, physicians have the tendency to tell the truth more often today than in the past, although the majority still disclose the truth to the next of kin. Nurses in Greece are considered to be the most suitable health care professionals for the patients to share their thoughts and feelings with. Nevertheless, the decision on information disclosure lies with the treating physician. In Greek society the patient's family plays an important role in the provision of care and information disclosure. They often decide on the patient's behalf.

Greek brief pain inventory: validation and utility in cancer pain.

OBJECTIVE: The Brief Pain Inventory (BPI) is a pain assessment tool. It has been translated into and validated in several languages. The purpose of this study was the translation into and validation of the BPI in Greek. Moreover, we wanted to detect cultural and social differences, if any, of pain interference in patients' lives. METHODS: The translation and validation of the inventory took place at the Areteion Hospital. The final validation sample consisted of 220 cancer patients (123 males, 97 females, age range 21-87 years, mean age 61.3). Primary cancer locations were lung 25.6%, gastrointestinal tract 25.6%, breast 11.5%, prostate 7.07%, gynecological cancers 9.6% and others 20.57%. The patients themselves completed the majority of the Greek BPI (G-BPI) papers. The pain management index (PMI) was also calculated in order to assess the adequacy of pain treatment. Assessing the reliability and the validity made the actual validation of the G-BPI. RESULTS: Pain severity and pain management: 147 patients reported severe pain, 48 patients moderate, and 25 patients mild pain (mean average pain 6.22). From these patients only 21 were found on strong and 33 on weak opioid treatment, while 166 patients were found on no opioid analgesic treatment. In agreement with these data is the PMI which was positive only for 9 patients, while 44 patients had PMI = 0 and all the others had negative PMI scores. Reliability and Validity of the G-BPI: Coefficient alphas were 0.849 for the interference items and 0.887 for the severity items. Additionally, the factor analysis of the G-BPI items results in a two-factor solution, that satisfies the criteria of reproducibility, interpretability and confirmatory setting. CONCLUSION: This study shows the efficacy of the G-BPI for the assessment of pain severity as well as the pain management in Greece, and therefore its utility in improving the analgesic treatment outcome in Greek patients.