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Berufsbezogene Beratung im Rahmen der Cancer-Rehabilitation-Support-by-Cancer-Counseling-Centers(CARES)-Studie

Abstract (Expand)

**Hintergrund** Bei Krebsbetroffenen im erwerbsfähigen Alter stellen sich von Diagnose und Behandlungsbeginn an zumeist auch arbeitsbezogene Fragestellungen. In der CARES-Studie (Cancer Rehabilitation … Support by Cancer Counseling Centers) wurden Berufslots\*innen in Krebsberatungsstellen (KBS) fortgebildet, die Ratsuchende rund um berufliche Themen unterstützen können. **Fragestellung** Wer nimmt das Berufslots\*innenangebot in Anspruch? Welche Vorteile und Optimierungsmöglichkeiten nehmen Ratsuchende, Berufslots\*innen und Zuweisende vom Berufslots\*innenprogramm wahr? **Methode** CARES ist eine quasiexperimentelle Machbarkeitsstudie. In 19 KBS wurden zunächst Ratsuchende vor Einführung des Berufslots\*innenprogramms (Vergleichsgruppe [VG]) und anschließend Ratsuchende nach Schulung der Berufslots\*innen (Interventionsgruppe [IG], vorläufige Ergebnisse) eingeschlossen. In diesem Beitrag werden Befragungsdaten zum ersten Befragungszeitpunkt zu Beginn der Beratung berichtet. Zudem wurden semistrukturierte Interviews geführt. Diese wurden inhaltsanalytisch ausgewertet. **Ergebnisse** Teilnehmende an CARES (VG: n = 293/IG: n = 326) waren mehrheitlich weiblich und hatten einen (Fach‑)Hochschulabschluss. An den Interviews nahmen 16 Ratsuchende, 11 Berufslots\*innen und 5 Zuweisende teil. Als Vorteile des Programms wurden u. a. die unmittelbare Unterstützung und Hilfe bei bürokratischen Prozessen, erhöhte zeitliche Kapazitäten sowie die Schließung einer Lücke in der Versorgungslandschaft genannt. Als Optimierungsmöglichkeiten wurden u. a. Beratungstermine in den Abendstunden bzw. im Onlineformat. **Schlussfolgerung** Ratsuchende, Berufslots\*innen wie auch Zuweisende nehmen das Berufslots\*innenprogramm als vorteilhaft wahr, z. B. als Möglichkeit, Patient\*innen mit Bedarf für Unterstützung bei beruflichen Themen zu verweisen und so eine Lücke in der Versorgung zu schließen.

Authors: Clara Breidenbach, Paula Heidkamp, Kati Hiltrop, Lina Heier, Johanna Weiß, Marie Rösler, Sabine Schneider, Sophie Schellack, Johannes Soff, Christoph Kowalski, Nicole Ernstmann

Date Published: 2nd Aug 2024

Publication Type: Journal

Cancer rehabilitation support by cancer counselling centres (CARES): study protocol of a quasi-experimental feasibility study.

Abstract (Expand)

INTRODUCTION: While maintaining or restoring work ability after a cancer diagnosis is an essential aim of the rehabilitation process for working-age patients, problems can arise during the return to … work (RTW) or when retaining work. Counselling could provide support for patients with or after cancer with employment-related questions (eg, questions related to RTW and work retention). Outpatient psychosocial cancer counselling centres in Germany offer counselling on work-related questions; however, resources for this are limited. This protocol presents a feasibility study of an intensified needs-based counselling intervention that supports those seeking employment-related advice. METHODS AND ANALYSIS: The CARES (cancer rehabilitation support by cancer counselling centres) project is a feasibility study for a newly developed counselling intervention. The intervention is being developed as part of the project and piloted in about 20 outpatient cancer counselling centres. The CARES study has a quasi-experimental pre-post design with a control cohort. First, patients who undergo regular counselling are recruited. Second, after the counsellors have been trained for the newly developed intervention, participants for the intervention group are recruited from the cancer counselling centres. Quantitative and formative evaluations will be performed in accordance with the existing guidelines. The quantitative evaluation comprises three patient surveys (at the beginning of the counselling process, 3 months into the counselling process and, for the intervention group, at the end of the counselling process) and routine data of the counselling process. The formative evaluation includes interviews with patients, counsellors and other stakeholders, as well as participatory observations of counselling sessions. ETHICS AND DISSEMINATION: Approval has been obtained from the ethics committee of the Medical Faculty of the University Bonn (061/22; 09.04.2022). A data protection concept ensures adherence to data protection regulations for the handled data. The dissemination strategies include discussing the results with the cancer counselling centres. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00028121); Pre-results.

Authors: K. Hiltrop, P. Heidkamp, C. Breidenbach, C. Kowalski, G. Bruns, N. Ernstmann

Date Published: 11th Aug 2023

Publication Type: Journal

Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)

Abstract (Expand)

PURPOSE In contrast to 5-azacytidine (5-aza), allogeneic stem-cell transplantation (HSCT) represents a curative treatment strategy for patients with myelodysplastic syndromes (MDS), but therapy-related …plastic syndromes (MDS), but therapy-related mortality (TRM) limits its broader use in elderly patients with MDS. The present prospective multicenter study compared HSCT following 5-aza pretreatment with continuous 5-aza treatment in patients with higher-risk MDS age 55-70 years. METHODS One hundred ninety patients with a median age of 63 years were enrolled. Patients received 4-6 cycles of 5-aza followed by HLA-compatible HSCT after reduced-intensity conditioning or by continuous 5-aza if no donor was identified. RESULTS Twenty-eight patients did not fulfill inclusion criteria (n = 20), died (n = 2) withdrew informed consent (n = 5), or were excluded for an unknown reason (n = 1). 5-aza induction started in 162 patients, but only 108 (67%) were eligible for subsequent allocation to HSCT (n = 81) or continuation of 5-aza (n = 27) because of disease progression (n = 26), death (n = 12), or other reasons (n = 16). Seven percent died during 5-aza before treatment allocation. The cumulative incidence of TRM after HSCT at 1 year was 19%. The event-free survival and overall survival after 5-aza pretreatment and treatment allocation at 3 years were 34% (95% CI, 22 to 47) and 50% (95% CI, 39 to 61) after allograft and 0% and 32% (95% CI, 14 to 52) after continuous 5-aza treatment ( P < .0001 and P = .12), respectively. Fourteen patients progressing after continuous 5-aza received a salvage allograft from an alternative donor, and 43% were alive at last follow-up. CONCLUSION In older patients with MDS, reduced-intensity conditioning HSCT resulted in a significantly improved event-free survival in comparison with continuous 5-aza therapy. Bridging with 5-aza to HSCT before is associated with a considerable rate of dropouts because of progression, mortality, and adverse events.

Authors: Nicolaus Kröger, Katja Sockel, Christine Wolschke, Wolfgang Bethge, Richard F. Schlenk, Dominik Wolf, Michael Stadler, Guido Kobbe, Gerald Wulf, Gesine Bug, Kerstin Schäfer-Eckart, Christof Scheid, Florian Nolte, Jan Krönke, Matthias Stelljes, Dietrich Beelen, Marion Heinzelmann, Detlef Haase, Hannes Buchner, Gabriele Bleckert, Aristoteles Giagounidis, Uwe Platzbecker

Date Published: 20th Oct 2021

Publication Type: Journal

A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients.

Abstract (Expand)

BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B … and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received >/=1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting). FINDINGS: Patients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received >/=1 dose of ASP0113 (n = 246) or placebo (n = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% (n = 87) with ASP0113 and 30*2% (n = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 (p = 0.027). INTERPRETATION: ASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups. FUNDING: Astellas Pharma Global Development, Inc .

Authors: P. Ljungman, A. Bermudez, A. C. Logan, M. A. Kharfan-Dabaja, P. Chevallier, R. Martino, G. Wulf, D. Selleslag, K. Kakihana, A. Langston, D. G. Lee, C. Solano, S. Okamoto, L. R. Smith, M. Boeckh, J. R. Wingard, B. Cywin, C. Fredericks, C. Lademacher, X. Wang, J. Young, J. Maertens

Date Published: 12th Apr 2021

Publication Type: Journal

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide.

Abstract (Expand)

INTRODUCTION: Lenalidomide plus dexamethasone is effective and well tolerated in relapsed/refractory multiple myeloma (RRMM). In this observational, noninterventional European post-authorization safety … study, the safety profile of lenalidomide plus dexamethasone was investigated and compared with that of other agents in the treatment of RRMM in a real-world setting. PATIENTS AND METHODS: Patients had received >/= 1 prior antimyeloma therapy; prior lenalidomide was excluded. Treatment was per investigator's routine practice. Adverse events were analyzed by incidence rates per 100 person-years to account for differences in observation length and treatment duration. RESULTS: In total, 2150 patients initiated lenalidomide, and 1479 initiated any other antimyeloma therapy, predominately bortezomib (80.3%), which was primarily administered intravenously (74.3%). The incidence rate of neuropathy was lower with lenalidomide (10.5) than with bortezomib (78.9) or thalidomide (38.7). Lenalidomide also had a lower incidence rate of infections (68.7) versus bortezomib (95.9) and thalidomide (76.0). Conversely, the incidence rate of neutropenia was higher with lenalidomide (38.0) than with bortezomib (18.2) or thalidomide (25.7). The incidence rates of thrombocytopenia were 24.4, 40.4, and 14.4 with lenalidomide, bortezomib, and thalidomide, respectively. CONCLUSION: No new safety signals for lenalidomide were identified in this study, which is the largest prospective real-world European study of lenalidomide in patients with RRMM to date. These results confirm that the safety profile of lenalidomide plus dexamethasone in RRMM in a real-world setting is comparable to that reported in clinical trials.

Authors: B. Gamberi, C. Berthou, M. Hernandez, G. Semenzato, E. Tholouli, R. Hajek, J. Caers, M. Dimopoulos, M. C. Minnema, B. Andreasson, J. Parreira, G. Crotty, K. Remes, E. Kueenburg, B. Rosettani, A. Di Micco, S. Peters, P. Bacon, I. W. Blau

Date Published: 2nd Jul 2020

Publication Type: Journal

Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.

Abstract (Expand)

The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in … newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.

Authors: H. Goldschmidt, E. K. Mai, J. Durig, C. Scheid, K. C. Weisel, C. Kunz, U. Bertsch, T. Hielscher, M. Merz, M. Munder, H. W. Lindemann, B. Hugle-Dorr, D. Tichy, N. Giesen, D. Hose, A. Seckinger, S. Huhn, S. Luntz, A. Jauch, A. Elmaagacli, B. Rabold, S. Fuhrmann, P. Brossart, M. Goerner, H. Bernhard, M. Hoffmann, J. Hillengass, M. S. Raab, I. W. Blau, M. Hanel, H. J. Salwender

Date Published: 9th Feb 2020

Publication Type: Journal

Peripheral neuropathy associated with subcutaneous or intravenous bortezomib in patients with newly diagnosed myeloma treated within the GMMG MM5 phase III trial.

Abstract

Not specified

Authors: M. Merz, H. Salwender, M. Haenel, E. K. Mai, U. Bertsch, C. Kunz, T. Hielscher, I. W. Blau, C. Scheid, D. Hose, A. Seckinger, A. Jauch, J. Hillengass, M. S. Raab, B. Schurich, M. Munder, P. Brossart, C. Gerecke, H. W. Lindemann, M. Zeis, K. Weisel, J. Duerig, H. Goldschmidt

Date Published: 20th Aug 2016

Publication Type: Journal

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