Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer.

INTRODUCTION: The Managing Cancer and Living Meaningfully (CALM) therapy for patients with advanced cancer was tested against a supportive psycho-oncological counseling intervention (SPI) in a randomized controlled trial (RCT). We investigated whether CALM was delivered as intended (therapists' adherence); whether CALM therapists with less experience in psycho-oncological care show higher adherence scores; and whether potential overlapping treatment elements between CALM and SPI can be identified (treatment differentiation). METHODS: Two trained and blinded raters assessed on 19 items four subscales of the Treatment Integrity Scale covering treatment domains of CALM (SC: Symptom Management and Communication with Health Care Providers; CSR: Changes in Self and Relationship with Others; SMP: Spiritual Well-being and Sense of Meaning and Purpose; FHM: Preparing for the Future, Sustaining Hope and Facing Mortality). A random sample of 150 audio recordings (75 CALM, 75 SPI) were rated on a three-point Likert scale with 1 = "adherent to some extent," 2 = "adherent to a sufficient extent," 3 = "very adherent." RESULTS: All 19 treatment elements were applied, but in various frequencies. CALM therapists most frequently explored symptoms and/or relationship to health care providers (SC_1: n_applied = 62; 83%) and allowed expression of sadness and anxiety about the progression of disease (FHM_2: n_applied = 62; 83%). The exploration of CALM treatment element SC_1 was most frequently implemented in a satisfactory or excellent manner (n_sufficient or very adherent = 34; 45%), whereas the treatment element SMP_4: Therapist promotes acknowledgment that some life goals may no longer be achievable (n_sufficient or very adherent = 0; 0%) was not implemented in a satisfactory manner. In terms of treatment differentiation, no treatment elements could be identified which were applied significantly more often by CALM therapists than by SPI therapists. CONCLUSION: Results verify the application of CALM treatment domains. However, CALM therapists' adherence scores indicated manual deviations. Furthermore, raters were not able to significantly distinguish CALM from SPI, implying that overlapping treatment elements were delivered to patients.

Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial.

OBJECTIVE: We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI). METHODS: Adult patients with advanced cancer and ≥9 points on the PHQ-9 and/or ≥5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI-II and the PHQ-9 6 months after baseline compared to SPI patients. RESULTS: From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention-to-treat analyses revealed significantly less depressive symptoms at 6 months than at baseline (P < .001 for BDI-II and PHQ-9), but participants in the CALM and SPI group did not differ in depression severity (BDI-II: P = .62, PHQ-9: P = .998). Group differences on secondary outcomes were statistically not significant either. CONCLUSIONS: CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.

Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients.

PURPOSE: The diagnosis of a terminal disease bears existential challenges, which activate the attachment system. Attachment insecurity, as well as existential resources, such as spiritual well-being, influences patients' extent of psychological distress. Knowledge about the interrelation of these constructs is limited. Based on current research, we assume spiritual well-being to mediate the association of attachment insecurity and psychological distress. METHODS: We obtained data from the baseline measurement of a randomized controlled trial in advanced cancer patients. Patients were sampled from the University Medical Centers of Hamburg and Leipzig, Germany. Main outcome measures included the Patient Health Questionnaire (PHQ-9), the Death and Dying Distress Scale (DADDS), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), and the Experience in Close Relationships Scale (ECR-M16) for assessing attachment insecurity. We tested the mediation hypothesis with two regression analyses using bootstrapping procedure. RESULTS: A total of 190 patients were included. Spiritual well-being mediated the association of attachment insecurity and depression (R2 = 11%), as well as death anxiety (R2 = 15%), in fearful-avoidant attached patients. Neither dismissingly nor preoccupied attached patients differ in terms of spiritual well-being and psychological distress in comparison with secure attached patients. CONCLUSION: Spiritual well-being plays a relevant role in advanced cancer patient's mental health through mediating the association of attachment and psychological distress. Developing a better understanding of the interdependency of the constructs of spiritual well-being and attachment can help to develop individually tailored advanced cancer care programs and psychotherapeutic interventions. TRIAL REGISTRATION: NCT02051660.

[Assessment of Couples' Communication in Patients with Advanced Cancer: Validation of a German Version of the Couple Communication Scale (CCS)]. / Die Erfassung der Paarkommunikation bei Patienten mit einer fortgeschrittenen Krebserkrankung: Validierung einer deutschen Version der Couple Communication Scale (CCS).

BACKGROUND: There are only a few valid instruments measuring couples' communication in patients with cancer for German speaking countries. The Couple Communication Scale (CCS) represents an established instrument to assess couples' communication. However, there is no evidence regarding the psychometric properties of the German version of the CCS until now and the assumed one factor structure of the CCS was not verified for patients with advanced cancer yet. METHOD: The CCS was validated as a part of the study "Managing cancer and living meaningfully" (CALM) on N=136 patients with advanced cancer (≥18 years, UICC-state III/IV). The psychometric properties of the scale were calculated (factor reliability, item reliability, average variance extracted [DEV]) and a confirmatory factor analysis was conducted (Maximum Likelihood Estimation). The concurrent validity was tested against symptoms of anxiety (GAD-7), depression (BDI-II) and attachment insecurity (ECR-M16). RESULTS: In the confirmatory factor analysis, the one factor structure showed a low, but acceptable model fit and explained on average 49% of every item's variance (DEV). The CCS has an excellent internal consistency (Cronbachs α=0,91) and was negatively associated with attachment insecurity (ECR-M16: anxiety: r=- 0,55, p<0,01; avoidance: r=- 0,42, p<0,01) as well as with anxiety (GAD-7: r=- 0,20, p<0,05) and depression (BDI-II: r=- 0,27, p<0,01). CONCLUSION: The CCS is a reliable and valid instrument measuring couples' communication in patients with advanced cancer.

Perceived doctor-patient relationship and its association with demoralization in patients with advanced cancer.

BACKGROUND: Advanced diseases pose a great burden on patients and go hand in hand with existential concerns. Demoralization is considered as a syndrome of existential distress with a perceived inability to cope with loss of meaning in life and feelings of helplessness and hopelessness. Professional health care providers play an important role in providing support for patients and unfavorable conversational styles in their relationship can increase patient's distress. In this study, we examine the association between the patient's perceived relationship to health care providers and demoralization. METHODS: We used baseline data of a randomized control trial intervention study for advanced cancer patients (UICC-Stage ≥ III; PHQ ≥ 9 and/or Distress-Thermometer ≥5). We used a subscale of the QUAL-EC-P for assessing doctor-patient relationship, Beck Depression Inventory-II for depressive symptoms, a modified version of the MSAS as physiological symptom checklist, and the Demoralization Scale to assess demoralization. A hierarchical regression analysis was calculated. RESULTS: In our sample of 187 patients with stage III or IV cancer (62% women), demoralization was present in 53.4% (16% moderate demoralization; 37.4% high demoralization) of the patients. Relationship to health care provider was an independent predictor (ß = -.33, t(186) = -6.70, P < .001) of demoralization. CONCLUSIONS: Our findings underline the importance of the physician-patient relationship in the context of coping with existential challenges in advanced cancer patients. Trainings on how to communicate and build a sustainable relationship with patients and their specific needs may increase the buffering effect of social support by the physicians on patient's existential distress.

Insecure attachment predicts depression and death anxiety in advanced cancer patients.

ABSTRACTObjective:The prevalence of depression as well as adjustment and anxiety disorders is high in advanced cancer patients, and research exploring intraindividual factors leading to high psychological distress is underrepresented. Cancer patients' feelings about security and trust in their healthcare providers have a significant influence on how they deal with their disease. The perception of social support is affected by patients' attachment styles and influences their reactions to feelings of dependency and loss of control. We therefore aimed to explore attachment and its association with psychological distress in patients with advanced cancer. METHOD: We obtained data from the baseline measurements of a randomized controlled trial in advanced cancer patients. Patients were sampled from the university medical centers of Hamburg and Leipzig, Germany. The main outcome measures included the Patient Health Questionnaire, the Death and Dying Distress Scale, the Memorial Symptom Assessment Scale, and the Experience in Close Relationships Scale for assessing attachment insecurity. RESULTS: A total of 162 patients were included. We found that 64% of patients were insecurely attached (fearful-avoidant 31%, dismissing 17%, and preoccupied 16%). A dismissing attachment style was associated with more physical symptoms but did not predict psychological distress. A fearful-avoidant attachment style significantly predicted higher death anxiety and depression, whereas preoccupied attachment predicted higher death anxiety only. Overall, insecure attachment contributed to the prediction of depression (10%) and death anxiety (14%). SIGNIFICANCE OF RESULTS: The concept of attachment plays a relevant role in advanced cancer patients' mental health. Healthcare providers can benefit from knowledge of advanced cancer patients' attachment styles and how they relate to specific mental distress. Developing a better understanding of patients' reactions to feelings of dependency and distressing emotions can help us to develop individually tailored advanced cancer care programs and psychotherapeutic interventions.

Measuring the Psychosocial Dimensions of Quality of Life in Patients With Advanced Cancer: Psychometrics of the German Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire.

CONTEXT: Quality of life (QoL) is a central focus of care in advanced cancer. Specialized instruments, such as the Quality of Life at the End of Life-Cancer (QUAL-EC), may be useful to assess psychosocial issues associated with QoL unique to this population. OBJECTIVES: To evaluate the measurement of the psychosocial dimensions of QoL using the German translation of the QUAL-EC-Psychosocial (QUAL-EC-P) questionnaire, including factor structure and psychometrics. METHODS: About 183 patients with advanced cancer from the University Medical Center Hamburg-Eppendorf and University Medical Center Leipzig completed the QUAL-EC-P questionnaire. We conducted exploratory factor analysis as well as item and reliability analysis. We examined convergent validity with correlations between the scale and relevant psychological constructs. RESULTS: The sample was 60% female with mean age of 57.7 (SD = 11.7). We extracted three factors accounting for 44% of the variance aligning with the structure of the instrument. The QUAL-EC-P questionnaire showed good to acceptable internal consistency for the QoL-psychosocial total score (α = 0.77), the Life completion subscale (α = 0.77), and the Relationship with health care provider subscale (α = 0.81). The Preparation for end of life subscale had adequate albeit low internal consistency (α = 0.64) because concerns about family were less associated with financial worry and fear of death than expected. The psychosocial dimensions of QoL correlated negatively with depression (r = -0.27, P ≤ 0.001), anxiety (r = -0.32, P ≤ 0.001), demoralization (r = -0.63, P ≤ 0.001), and attachment insecurity (r = -0.51, P ≤ 0.001) and positively with spiritual well-being (r = 0.63, P ≤ 0.001). CONCLUSION: The QUAL-EC-P questionnaire may be used to assess the psychosocial aspects of QoL and promote their clinical discussion in patients with advanced cancer.

Attachment Insecurity in Advanced Cancer Patients: Psychometric Properties of the German Version of the Brief Experiences in Close Relationships Scale (ECR-M16-G).

CONTEXT: Attachment insecurity refers to difficulty in trusting and relying on others in times of need. Its underlying factors attachment anxiety and attachment avoidance have been empirically associated with impaired coping in advanced cancer and, therefore, should be considered in individually tailored medical and psychosocial treatment. OBJECTIVES: The objective of this study was to evaluate the psychometric properties of the German translation of the Brief Experiences in Close Relationships Scale (ECR-M16-G). METHODS: We recruited 182 advanced cancer patients from outpatient psycho-oncology clinics of the University Medical Center Hamburg-Eppendorf and the University Medical Center Leipzig, local and external cancer care facilities. We performed confirmatory factor analysis to replicate the higher order factor structure reported in previous research. We conducted item and reliability analysis, also correlation analysis, to examine concurrent validity. RESULTS: One hundred fifty-eight patients completed the ECR-M16-G (women 61%, mean age 57.9, SD = 11.1). We replicated the factor structure with the subscales Attachment Anxiety and Attachment Avoidance as second-order factors and Worrying about relationships, Frustration about unavailability, Discomfort with close others, and Turning away from others as first-order factors. An adjusted model that interchanged factor loadings of items 4 and 10 showed good fit (Comparative Fit Index = 0.94, Non-Normed Fit Index = 0.93, root mean square error of approximation = 0.05). Subscales showed acceptable to good internal consistency (anxiety α = .81 and avoidance α = .78). Attachment insecurity (mean = 3.1, SD = 1.0) was positively associated with depression, anxiety, demoralization (P < 0.001), and symptom burden (P = 0.02) and negatively associated with spiritual well-being (P < 0.001). CONCLUSION: The ECR-M16-G is a valid and reliable measure of attachment insecurity in patients with advanced cancer and can be recommended as a tool for clinical care and further research.

Death-Related Anxiety in Patients With Advanced Cancer: Validation of the German Version of the Death and Dying Distress Scale.

CONTEXT: Distress and anxiety about issues related to death and dying is commonly experienced in patients with advanced disease and a limited life expectancy. OBJECTIVES: To evaluate the psychometric properties of the German version of the Death and Dying Distress Scale (DADDS-G) in advanced cancer patients. METHODS: We recruited advanced patients with mixed tumor entities (Union for International Cancer Control [UICC] Stage III/IV) treated in two German University Medical Centers during their outpatient treatment. After testing a preliminary version of the state-of-the-art translated original Death and Dying Distress Scale, we analyzed the psychometric properties of the shortened nine-item adapted DADDS-G using validated instruments measuring distress, anxiety, depression, fear of progression, and quality of life. RESULTS: We obtained complete questionnaires from 77 of 93 patients with advanced cancer (response rate: 83%). Participants were mostly married or cohabiting (75%), well-educated, and both sexes were almost equally represented (52% men; mean age 58 years, SD = 12). The total mean DADDS-G score was 13.3 (SD = 8.5). Patients reported to be most distressed by the feeling of being a burden to others. The exploratory factor analysis led to one factor that accounted for more than 59% of the variance. The DADDS-G's internal consistency was excellent with Cronbach alpha = 0.91. The confirmatory factor analysis demonstrated a very good model fit. Death-related anxiety was significantly associated with distress, depression, anxiety, fear of progression, and lower quality of life (P < 0.001). CONCLUSION: Results provide further evidence that the DADDS-G is a valid and reliable instrument of high clinical relevance for use in patients with advanced cancer.

Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial.

BACKGROUND: Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings. METHODS/DESIGN: We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline. DISCUSSION: Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02051660.

[Prevalence of adjustment disorder, acute and posttraumatic stress disorders as well as somatoform disorders in cancer patients]. / Prävalenz von Anpassungsstörung, Akuter und Posttraumati-scher Belastungsstörung sowie somatoformen Störungen bei Krebspatienten.

We aimed to systematically summarize the empirical evidence on the 4-week-, 12-month-, and lifetime prevalence of adjustment disorders, acute and posttraumatic stress disorders as well as somatoform disorders in cancer patients. We evaluated 64 English or German language original papers and systematic reviews that assessed the prevalence of affective and anxiety disorders using structured clinical interviews published between 1995 and 2010. Adjusted prevalence rates were calculated using a random-intercept model. We found the following pooled adjusted 4-week prevalence rates: For adjustment disorder 12.5% (95% CI 9.9-15.7), for posttraumatic stress disorder 2.6% (95% CI 1.7-4.0), for acute stress disorder 4.8% (95% CI 2.2-10.0) and for somatoform disorders 3.1% (95% CI 1.6-5.8). Our findings show the need for further research on representative studies that take into account the range of psychosocial stressors and supportive care needs.