Development and validation of a scale to measure socioeconomic well-being in persons with cancer

Socioeconomic factors substantially impact the quality of life (QOL) of persons diagnosed with cancer, yet socioeconomic well-being seldom is included as an essential domain when overall QOL is measured. This study details the development and psychometric analysis of a scale for measuring socioeconomic well-being in persons diagnosed with cancer. Coleman's theory of social class was used to define and develop the construct. The resulting scale consisting of two subscales--Material and Social Capital-demonstrated acceptable reliability, content and construct validity at both scale and item levels, and acceptable discriminant, convergent, and incremental validity.     

Prediction of prostate cancer in unscreened men: external validation of a risk calculator

Background

Prediction models need external validation to assess their value beyond the setting where the model was derived from.

Objective

To assess the external validity of the European Randomized study of Screening for Prostate Cancer (ERSPC) risk calculator (www.prostatecancer-riskcalculator.com) for the probability of having a positive prostate biopsy (P(posb)).

Design, setting and participants

The ERSPC risk calculator was based on data of the initial screening round of the ERSPC section Rotterdam and validated in 1825 and 531 men biopsied at the initial screening round in the Finnish and Swedish sections of the ERSPC respectively. P(posb) was calculated using serum prostate specific antigen (PSA), outcome of digital rectal examination (DRE), transrectal ultrasound and ultrasound assessed prostate volume.

Measurements

The external validity was assessed for the presence of cancer at biopsy by calibration (agreement between observed and predicted outcomes), discrimination (separation of those with and without cancer), and decision curves (for clinical usefulness).

Results and limitations

Prostate cancer was detected in 469 men (26%) of the Finnish cohort and in 124 men (23%) of the Swedish cohort. Systematic miscalibration was present in both cohorts (mean predicted probability 34% versus 26% observed, and 29% versus 23% observed, both p < 0.001). The areas under the curves were 0.76 and 0.78, and substantially lower for the model with PSA only (0.64 and 0.68 respectively). The model proved clinically useful for any decision threshold compared with a model with PSA only, PSA and DRE, or biopsying all men. A limitation is that the model is based on sextant biopsies results.

Conclusions

The ERSPC risk calculator discriminated well between those with and without prostate cancer among initially screened men, but overestimated the risk of a positive biopsy. Further research is necessary to assess the performance and applicability of the ERSPC risk calculator when a clinical setting is considered rather than a screening setting.     

The experiences of unpartnered men with prostate cancer: a qualitative analysis

Purpose  

The purpose of this study was to examine how men without partners make decisions about prostate cancer treatment, manage treatment side effects, and obtain information and support.     

Development and validation of a prognostic index for fracture risk in older men undergoing prostate cancer treatment

ObjectivesMen treated with androgen deprivation therapy (ADT) or radiation therapy (RT) for prostate cancer have an increased risk for fractures. Given uncertainty as to whether specific clinical factors can identify men at increased risk, we sought to develop a prognostic index for risk of fracture in this population.Materials and methodsWe used the Surveillance, Epidemiology, and End Results-Medicare database to identify men who received ADT or RT after being diagnosed with localized prostate cancer in 2007–2009. Cox proportional hazards models tested the association of potential risk factors with fracture. In a derivation group, hazard ratios were used to assign points for factors independently related to fracture. The prognostic index was then applied to a validation group.ResultsThe sample of 5824 men had a median age of 73.0 years; 82.9% were white and 8.6% had a fracture within 2 years of treatment for prostate cancer. The Cox model identified 8 variables (age, race, hormone treatment, Elixhauser score, anxiety, Parkinson's, fall-inducing medications and disability status) independently associated with fracture. In the derivation cohort, 4.3% of the sample experienced a fracture in the low-risk group, 8.9% in the intermediate group, and 19.2% in the high-risk group (C statistic, 0.749). The index was applied to the validation cohort (C statistic, 0.782).ConclusionThe prognostic index can help to identify patients at increased risk for fracture. This underscores the importance of identifying risk factors for fracture, given the substantial variation in fracture risk in men treated with ADT or RT.     

Predictors of new screening for African American men participating in a prostate cancer educational program

Background. African American (AA) men continue to have a greater than twofold risk of dying from prostate cancer compared to Whites. Methods. This community-based intervention study employed a quasi-experimental, delayed-control (cross-over) design with randomization at the church-level (N=345 AA men). Results. Logistic regression analyses revealed that the level of knowledge (b=.61, P<.05, Exp (B)=1.84), the perception of risk (b=2.99, P<.01, Exp (B)=19.95), and having insurance (b=3.20, P<.01, Exp (B)=24.65) significantly increased the odds of participants who needed screening getting screened during study. Discussion. This study demonstrated the need for education, community involvement, and increased access to encourage minority men to obtain needed health screenings.     

Clinical utility, factor analysis, and further validation of the memorial delirium assessment scale in patients with advanced cancer: Assessing delirium in advanced cancer

BACKGROUND: Delirium is a common neuropsychiatric complication in patients with advanced cancer. The Memorial Delirium Assessment Scale (MDAS) is a recently developed 10-item severity rating instrument. The purpose of the current prospective study was to further assess the clinical utility, factor structure, and validity of the MDAS in a relatively homogeneous population of patients with advanced cancer. METHODS: Study entry of 104 patients occurred on their consecutive admission to a tertiary-level, acute palliative care unit in a university-affiliated teaching hospital. Patients underwent regular cognitive screening using the Mini-Mental State Examination, and serial monitoring of delirium using standardized semistructured interviews and MDAS ratings, up to the study endpoints of either patient discharge or death. RESULTS: Seventy-one patients met Diagnostic and Statistical Manual (of Mental Disorders)-IV criteria for a first episode of delirium. In 15 of 71 (21%) patients with a first episode of delirium, the first MDAS ratings were prorated because of dyspnea, fatigue, or profound delirium. In the remaining 56 patients (79%), the first MDAS ratings were rated fully and therefore evaluable. Correlations among the scale items ranged from moderate to low (correlation coefficient [r] = 0.68-0.02). Analysis of the pattern of factor loadings identified two primary correlated factors: global cognitive (Factor I) and neurobehavioral (Factor II) (r = 0.33). Cronbach alpha coefficients for Factors I and II were 0.8 and 0.66, respectively, indicating a relatively high level of correlation for items within each. The Cronbach alpha coefficient for all 10 items was 0.78, suggesting a general underlying factor. In a larger sample of complete MDAS ratings (n = 330) a cutoff total MDAS score of 7 of 30 yielded the highest sensitivity (98%) and specificity (96%) for delirium diagnosis. The MDAS was correlated moderately with the Mini-Mental State Examination (r = 0.55). CONCLUSIONS: The authors concluded that the MDAS structure is representative of the many features of delirium, broadly grouped as global cognitive and neurobehavioral dimensions. Prorating item scores is necessary in approximately 20% of advanced cancer patients with delirium. This poses potential limitations on the applicability of the MDAS in research. Conversely, the ability to prorate item scores confers a clinical advantage to the instrument when assessing delirium in a patient population with advanced cancer.     

Methylphenidate for fatigue in ambulatory men with prostate cancer

BACKGROUND:

Fatigue is a highly prevalent and clinically significant symptom of advanced prostate cancer. To date, however, there are no published controlled trials of interventions for fatigue in men with prostate cancer.

METHODS:

This 6‐week, randomized, double‐blind, placebo‐controlled design evaluated the efficacy of methylphenidate to treat fatigue in prostate cancer patients. Inclusion criteria included men with advanced prostate cancer and the presence of moderate to severe fatigue. Patients with major depression, hypothyroidism, uncontrolled hypertension, arrhythmia, or anemia were excluded. Fatigue levels, blood pressure, pulse, and other safety concerns were monitored regularly.

RESULTS:

Thirty‐two subjects were randomized to methylphenidate (n = 16) or placebo (n = 16). Brief Fatigue Inventory total scores significantly decreased for both groups; however, the methylphenidate group, as compared with placebo, reported greater decrease on Brief Fatigue Inventory severity scores (P = .03) and a trend toward greater decrease on Brief Fatigue Inventory total scores (P = .07). A significantly greater number of subjects in the methylphenidate group versus the placebo group demonstrated clinically significant improvement in fatigue on total Brief Fatigue Inventory scores (7 of 10 vs 3 of 13) and Brief Fatigue Inventory severity scores (8 of 10 vs 3 of 13). Importantly, 6 subjects in the methylphenidate group discontinued because of increased blood pressure or tachycardia. There were no serious adverse events.

CONCLUSIONS:

Methylphenidate is effective in treating fatigue in men with prostate cancer; however, oncologists need to monitor for possible pulse and blood pressure elevations. Cancer 2010. © 2010 American Cancer Society.     

Cognitive effects of hormone therapy in men with prostate cancer: a review

BACKGROUND: Men who receive androgen-deprivation therapy (ADT) for prostate cancer experience several side effects from this treatment. A few recent studies have examined the cognitive implications of ADT and how they impact a patient's treatment decision-making, occupational pursuits, and quality of life. For this report, the authors explored possible mechanisms for this association, reviewed research in animal studies and aging men, and examined the growing literature focused on the relation between ADT and cognitive functioning in patients with prostate cancer. METHODS: A systematic literature search was conducted using the PubMed and Information Sciences Institute Web of Knowledge-Web of Science databases to identify relevant studies that investigated the relation between ADT in men with prostate cancer and its cognitive effects. RESULTS: Testosterone and its derivatives may have an impact on cognition through several mechanisms in the brain, as supported by studies of animals and in aging men. Studies that researched the impact of ADT on cognition in patients with prostate cancer patients were designed relatively well but suffered from small sample sizes. Between 47% and 69% of men on ADT declined in at least 1 cognitive area, most commonly in visuospatial abilities and executive functioning. Some studies reported contradictory results with increased functioning in verbal memory. CONCLUSIONS: There is a strong argument that androgen-ablation therapy is linked to subtle but significant cognitive declines in men with prostate cancer. The authors believe that clinicians should become aware of this correlation as the use of ADT increases and should inform and monitor patients for this possible side effect of treatment.     

Evidence for cure of 'young' men with prostate cancer

A study was undertaken to evaluate the question of cure in "young" men with prostate cancer treated by external-beam radiation. Results in young men (< or = 65 years) were compared to older men. Biochemical freedom from failure was examined to 10 years' follow-up, and hazard functions for failure vs time were reported. Results show that prostate cancer patients are cured by external-beam radiation and that there is no difference in results for young or older men. Few failures occur after 5 years' follow-up and the percentage cured is similar to that with prostatectomy, with much less morbidity. Appropriate dose is necessary to optimize outcome.     

Permanent prostate brachytherapy in men with clinically localised prostate cancer

Permanent prostate brachytherapy techniques are associated with excellent biochemical control for patients with localised prostate cancer. Ten-year data show that permanent prostate brachytherapy is compatible with external beam irradiation or radical prostatectomy. However, treatment protocols and techniques for prostate brachytherapy vary between centres and there is little conformity of treatment protocols. The selection of patients for monotherapy or combined external beam irradiation and brachytherapy is controversial. The role of neoadjuvant androgen deprivation also remains unanswered in patients with localised prostate cancer. In addition, post-implant dosimetry may in fact be more significant for predicting outcome than the addition of adjuvant therapies, and should be a requirement when performing prostate brachytherapy. Data now seem to support specific computed tomography (CT)-based criteria to evaluate implant quality and delivered dose to the prostate. Unfortunately, prostate oedema and poor imaging techniques are limiting factors for evaluating implant dosimetry. Treatment planning techniques that use new treatment planning computers may assist in improving the implant procedure and dosimetry and are now available.     

"Between Men": a psychosocial rehabilitation programme for men with prostate cancer

The aim of this study was to evaluate the effect of psychosocial rehabilitation on newly diagnosed prostate cancer patients. The “Between Men” programme consisted of seven weekly sessions of physical training (Phys) alone, information (Info) alone or physical training plus information (PhysInfo). After diagnoses, patients (n =211) were consecutively included, stratified and randomised to one of four groups: Phys, Info, PhysInfo or standard care control (C). A nurse specialised in urology, an urologist and a physiotherapist performed the interventions. Patients were followed up during one year with mailed standardised questionnaires. It could not be assumed that the “Between Men” programme had any effect on patients' anxiety and depression (HADS). Health-related quality of life (HRQOL) was associated with stage of disease but not with psychosocial intervention. Thus, Physical Function (PF), Role Function (RF) and Fatigue (FA) were inferior among patients with, than without, metastases of prostate cancer both at baseline and at the 12-month follow-up. This randomized study did not demonstrate any significant effect of psychosocial rehabilitation among prostate cancer patients. Considering the low rate (1/2), of included/eligible patients a less complicated design (intervention versus control) would have been preferred in order to increase power.     

Insomnia in men treated with radical prostatectomy for prostate cancer

This study assessed the prevalence, clinical characteristics and risk factors for insomnia in patients treated with radical prostatectomy for prostate cancer. A total of 327 patients completed a battery of questionnaires assessing sleep and related issues (i.e. anxiety, depression, fatigue, quality of life). Results indicated that 31.5% of the patients currently reported non-specific sleep difficulties, while 18% met specific criteria for an insomnia syndrome. In most of these latter cases (95%), the insomnia was chronic (duration of 6 months or more). Nearly half of patients with an insomnia syndrome reported that the onset of their sleep difficulties followed the cancer diagnosis. A similar proportion had no comorbid clinical levels of anxiety or depression. Risk factors for the presence of an insomnia syndrome included a younger age, a worse prognosis, and the presence of intestinal, pain, depressive, and androgen blockade-related symptoms. Thus, insomnia is a frequent problem associated with prostate cancer, that often occurs independently of anxiety and depression, but seems to be influenced by the presence of physical and psychological symptoms associated with prostate cancer and its treatment.