Emotional adjustment over 1 year post-diagnosis in patients with cancer: understanding and predicting adjustment trajectories.

PURPOSE: The aim of this study was to determine the prevalence of basic trajectories in emotional adjustment in cancer survivors and identify predictors of long-term change. METHODS: We assessed 421 patients with cancer after diagnosis and 6 and 12 months later. Measures comprised anxiety, depression, perceived support, desired support, and illness intrusiveness. RESULTS: Anxiety decreased over time, whereas depression increased as did need for support. About one third of initial diagnostic classifications (into low distress, symptoms, or clinical level of distress) changed from one assessment to the next. Lower age and higher illness intrusiveness predicted which patient showed worse adjustment over time. CONCLUSION: To avoid both over- and undertreatment of distressed individuals, repeated measurements are needed to identify actual adjustment trajectories. Initial assessment of emotional reaction to a diagnosis is not a reliable predictor of long-term adjustment. Patients should be made aware that completion of initial medical treatment even when accompanied by a positive prognosis does not in and of itself forecast how well patients adjust during survivorship.

Disease stage predicts post-diagnosis anxiety and depression only in some types of cancer.

BACKGROUND: We hypothesised that patients with advanced disease or a cancer type that has a poor prognosis may be more likely to report anxiety and depressive symptoms after diagnosis; younger age and female gender may moderate these effects. METHODS: Patients (n=3850) were consecutively assessed with PSSCAN, a standardised, validated tool, at two large cancer centres between 2004 and 2009. RESULTS: Female patients reported more anxiety and depressive symptoms (P=0.003 to P<0.001) compared with men and a healthy comparison group. Older age was associated with fewer anxiety (P=0.033 to P<0.001) and fewer depressive symptoms (P<0.001), but this was not true for lung cancer. Presence of metastases was associated with more anxiety symptoms in patients with gastrointestinal (P=0.044; R(2)Δ=0.001), lung (P=0.011; R(2)Δ=0.016), and prostate (P=0.032; R(2)Δ=0.008) cancer, but this was not true for breast cancer. Furthermore, early disease stage was associated with fewer depressive symptoms among older prostate cancer patients (P=0.021; R(2)Δ=0.008). Men with early lung cancer reported fewer anxiety (P=0.020; R(2)Δ=0.013) and depressive (P=0.017; R(2)Δ=0.016) symptoms than men with advanced disease or women. CONCLUSION: As hypothesised, disease stage was directly associated with emotional distress, except for patients with breast cancer. Furthermore, age and gender moderated some of these effects.

Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer.

Decision aids in North American breast cancer outpatients have been shown to assist with treatment decision making and reduce decisional conflict. To date, appropriate delivery formats to effectively increase patient participation in newly diagnosed breast cancer inpatients have not been investigated in the context of German health care provision. The impact of a decision aid intervention was studied in patients (n=111) with a strong suspicion of breast cancer in a randomised controlled trial. The primary outcome variable was decisional conflict. Participants were followed up 1 week post-intervention with a retention rate of 92%. Analyses revealed that the intervention group felt better informed (eta(p)(2)=0.06) but did not experience an overall reduction in decisional conflict as compared with the control group. The intervention had no effect on uptake rates of treatment options, length of consultation with the surgeon, time point of treatment decision making, perceived involvement in decision making, neither decision related nor general patient satisfaction. Patients who received the decision aid intervention experienced a small benefit with regards to how informed they felt about advantages and disadvantages of relevant treatment options. Results are discussed in terms of contextual factors and individual differences as moderators of treatment decision aid effectiveness.

The psychosocial screen for cancer (PSSCAN): further validation and normative data.

BACKGROUND: We have previously reported on the development of a cancer-specific screening instrument for anxiety and depression (PSSCAN). No information on cut-off scores or their meaning for diagnosis was available when PSSCAN was first described. Needed were additional analyses to recommend empirically justified cut-off scores as well as data norms for healthy adult samples so as to lend meaning to the recommended cut-off scores. METHODS: We computed sensitivity/specificity indices based on a sample of 101 cancer patients who had provided PSSCAN data on anxiety and depression and who had completed another standardized instrument with strong psychometrics. Next, we compared mean scores for four samples with known differences in health status, a healthy community sample (n = 561), a sample of patients with a representative mix of cancer subtypes (n = 570), a more severely ill sample of in-patients with cancer (n = 78), and a community sample with a chronic illness other than cancer (n = 85). RESULTS: Sensitivity/specificity analyses revealed that an excellent balance of sensitivity/specificity was achievable with 92%/98% respectively for clinical anxiety and 100% and 86% respectively for clinical depression. Newly diagnosed patients with cancer were no more anxious than healthy community controls but showed elevations in depression scores. Both, patients with chronic illness other than cancer and those with longer-standing cancer diagnoses revealed greater levels of distress than newly diagnosed cancer patients or healthy adult controls. CONCLUSION: These additional data on criterion validity and community versus patient norms for PSSCAN serve to enhance its utility for clinical practice.

Development and first validation of the shared decision-making questionnaire (SDM-Q).

OBJECTIVE: Due to a lack of valid German instruments measuring shared decision-making (SDM), a theory-driven questionnaire (SDM-Q) to measure the process of SDM was developed and validated. METHODS: As a theoretical basis steps of the SDM process were defined in an expert panel. Item formulation was then conducted according to the Delphi method. For the first validation on a mixed sample Rasch analysis was used to eliminate items not fitting the construct thus receiving a unidimensional scale. RESULTS: After eliminating 4 items the remaining 11 form a unidimensional scale with an acceptable reliability for person measures (0.77) and very good reliability for item difficulties (0.95). Analysis of subgroups revealed a different use of items in different conditions. Furthermore the scale showed high ceiling effects. CONCLUSION: A new theory-driven instrument to measure the process of SDM has been developed and validated by use of a rigorous method revealing first promising results. Yet the ceiling effects require the addition of more discriminating items, and the different use of items in different conditions demands an in depth analysis. PRACTICE IMPLICATIONS: While the concept of SDM is constantly receiving more attention in medical practice, its valid and reliable measurement remains challenging.

Measuring symptoms in localized prostate cancer: a systematic review of assessment instruments.

It is critical for prostate cancer researchers and clinicians to have access to comprehensive, sensitive and simple-to-use symptom measures that allow them to understand and quantify the subjective patient experience. The purpose of the current review is to provide a comprehensive review, detailed tool descriptions and objectively defined quality criteria to facilitate tool choices for patients with localized prostate cancer. Using a systematic web-based literature search, we found n=29 prostate symptom measures described in n=35 validation studies. To be recommended, tools needed to meet four criteria: broad domain coverage, ability to differentiate objective and subjective experience, good internal consistency and validation in at least two populations and/or having achieved two types of validations. Of the 29 tools reviewed, n=7 meet our criteria for recommendation, and three in particular (the EPIC-26 (Expanded Prostate Cancer Index Composite)-26, PC-QOL (Prostate Cancer-Quality of Life) and the UCLA-PCI (UCLA Prostate Cancer Index)) showed the strongest psychometrics. There is a reasonable number of measures to choose from that meet criteria for good psychometrics.

Dose-dense intensified sequential versus conventionally-dosed anthracycline and taxane-containing neoadjuvant therapy in patients with inflammatory breast cancer.

BACKGROUND: This post-hoc analysis aimed to compare an intense dose-dense sequential chemotherapy (DD-CT) and a conventionally-dosed chemotherapy (CD-CT) in the neoadjuvant AGO-1 study, focusing on the subgroup with inflammatory breast cancer (IBC). PATIENTS AND METHODS: Out of 668 randomised patients, 101 patients presented with IBC. Patients received epirubicin followed by paclitaxel every 2 weeks (DD-CT) or simultaneously every 3 weeks (CD-CT). RESULTS: No differences in pathological complete response rates were observed [odds ratio (OR)=1.27, p=0.33]. Most patients were scheduled for mastectomy before starting therapy; however, in 21.7% breast-conserving surgery was performed. Disease-free survival rates [Hazard Ratio (HR)=0.65; p=0.597] and overall survival rates (HR=1.40; p=0.327) were similar for both treatment arms. Patients with breast-conserving surgery had a significantly better outcome than patients treated with mastectomy (disease-free survival: HR=0.41; p=0.034 and overall survival: HR=0.09; p=0.003). CONCLUSION: Patients with IBC benefited not from DD-CT but from breast-conserving surgery after neoadjuvant chemotherapy.

[Shared decision making in breast cancer patients--qualitative study on mutual decision making in breast cancer in a university hospital]. / Shared Decision Making bei Brustkrebspatientinnen. Qualitative Untersuchung zur gemeinsamen Entscheidungsfindung beim Mammakarzinom in einer Universitätsklinik.

This qualitative study examines doctor-patient interactions and interviews with breast cancer patients referring to shared decision making. The interviews have been evaluated according to the method of grounded theory. Videos of doctor-patient interactions show information and discussions on therapy planning. Breast cancer is a serious, in many cases life-threatening disease. The primary therapy is characterised by confrontation with the diagnosis, fear and hope of the patients and the subsequent treatment. Central themes of the article are the context and implicit assumptions of doctors influencing the shared decision making approach.

[Development and validation of assessment instruments for shared decision making]. / Entwicklung eines Fragebogens zur Partizipativen Entscheidungsfindung.

The German Ministry for Health and Social Security is funding ten projects to introduce shared decision making into clinical practice. The medical problems the projects are focussing on were chosen from among various diseases (e. g. depression, multiple sclerosis, cancer). The ten projects achieved consensus on a core set of instruments for the measurement of process and outcome of the shared decision making. Instruments developed in German-speaking countries are currently not available. Thus, linguistic and cultural validation had to be performed for the core set instruments. The results of the data analysis as well as patient interviews demonstrate the need for improving these instruments. Therefore, the members of the methodological working group concentrated on the integration of these results in a new instrument. In a first step the construct of "shared decision making" was defined, followed by a definition of the process elements characterising shared decision making. Thereafter, items were developed on the basis of the process elements. The new instrument will now be validated for different diseases.