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Objective: Cancer patients parenting minor children face specific burden and supportive needs, which are often not adequately addressed by their healthcare professionals (HCPs), due to a lack of knowledge, self‐efficacy and competencies. Therefore, we developed a 3‐h intervention enhancing HCPs' competencies in caring for these patients. We pilot‐evaluated the intervention's feasibility and efficacy, assuming intervention group participants reveal higher improvements over time compared to non‐trained participants. Methods: We conducted a 3‐armed randomized controlled pilot‐trial (RCT), comparing face‐to‐face training (F2F), e‐Learning (EL), waitlist‐control group with three measurements (baseline, post‐training, 3‐month follow‐up). Primary outcome was the competency to approach child‐ and family‐related themes; secondary outcomes were knowledge, self‐efficacy in (specific) communication skills. Intervention effects were analyzed using linear mixed models. Results: Participants (n = 152) were mostly female (89%) and psychologists (38%; physicians 26%; nurses 18%). F2F and EL participants reported high training satisfaction. Analyses did not reveal any significant differences on the primary outcome between groups, but indicate positive intervention effects over time regarding secondary outcomes including knowledge and self‐efficacy in communication skills. Conclusions: This is the first pilot‐study evaluating a training for HCPs in oncology on parental cancer using a 3‐armed RCT. The 3‐h training program is a feasible approach and findings indicate to increase HCPs' knowledge and self‐efficacy in caring for cancer patients with minor children. Further research is needed to verify preliminary findings of this pilot study. The study was pre‐registered within the German Clinical Trial Register (DRKS‐00015794). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: Close relationships can be strained by losses related to independence, autonomy, and separation after diagnosis of severe illness. The perceived quality of their close relationships affects individuals' psychological adaptation in this context. We explored the level of perceived relatedness and its impact on demoralization and death acceptance. We further examined a possible protective effect of perceived relatedness on the association between tumor stage and death acceptance.Methods: For this observational study, we consecutively recruited gynecology outpatients and general surgery inpatients at the University Cancer Center Hamburg-Eppendorf and oncological inpatients at the LungenClinic Grosshansdorf, Germany. At baseline, 307 patients (age M = 59.6, 69% female, 69% advanced cancer) participated. At 6- and 12-month (T3) follow-up, 213 and 153 patients responded, respectively. Patients completed self-report questionnaires including a modified version of the Posttraumatic Growth Inventory assessing perceived relatedness, the Life Attitude Profile-Revised assessing death acceptance, the Demoralization Scale, and the Memorial Symptom Assessment Scale assessing symptom burden. We calculated multiple linear regression analyses controlling for demographic and disease-related factors.Results: Participants reported a stronger perceived relatedness at baseline (M = 3.04, SE = 0.03, possible range 0-4) than at T3 (M = 2.93, SE = 0.04; p = 0.02). Perceived relatedness significantly predicted lower demoralization at T3 but did not moderate the relationship between tumor stage and demoralization. Apart from male gender, none of the predictor or moderator variables had a significant impact on death acceptance at T3.Conclusions: The strong impact of perceived relatedness on existential distress emphasizes the importance of strengthening interpersonal relationships within psychosocial interventions. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]