Lymphoma InterVEntion (LIVE) - patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial.

BACKGROUND: Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management. Moreover, self-management interventions intend to enhance knowledge and skills and empower patients to better manage their disease and related problems. The objective of the Lymphoma InterVEntion (LIVE) trial is to examine whether feedback to patients on their PROs and access to a web-based, self-management intervention named Living with lymphoma will increase self-management skills and satisfaction with information, and reduce psychological distress. METHODS/DESIGN: The LIVE randomised controlled trial consists of three arms: (1) standard care, (2) PRO feedback, and (3) PRO feedback and the Living with lymphoma intervention. Patients who have been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, including chronic lymphocytic leukaemia, as registered in the Netherlands Cancer Registry in various hospitals will be selected for participation. Patients are invited via their haemato-oncologist 6 to 15 months after diagnosis. The PRO feedback includes a graphical overview of patients' own symptom and functioning scores and an option to compare their scores with those of other patients with lymphoma and a normative population of the same age and sex. The Living with lymphoma intervention is based on cognitive behavioural therapy components and includes information, assignments, assessments, and videos. Changes in outcomes from baseline to 16 weeks, 12, and 24 months post intervention will be measured. Primary outcomes are self-management skills, satisfaction with information, and psychological distress. Secondary outcomes are health-related quality of life, illness perceptions, fatigue, and health care use. DISCUSSION/DESIGN: The results of the LIVE trial will provide novel insights into whether access to PRO feedback and the Living with lymphoma intervention will be effective in increasing self-management skills and satisfaction with information, and reducing distress. The LIVE trial is embedded in a population-based registry, which provides a unique setting to ascertain information on response, uptake, and characteristics of patients with lymphoma in web-based intervention(s). When effective, PRO feedback and Living with lymphoma could serve as easily and widely accessible interventions for coping with lymphoma. TRIAL REGISTRATION: Netherlands Trial Register, identifier NTR5953 . Registered on 14 July 2016.

Monosomal karyotype as an adverse prognostic factor in patients with acute myeloid leukemia treated with allogeneic hematopoietic stem-cell transplantation in first complete remission: a retrospective survey on behalf of the ALWP of the EBMT.

Despite the overall benefit from allogeneic hematopoietic stem cell transplantation observed in patients with poor cytogenetic risk acute myeloid leukemia in first complete remission, the precise effect of this procedure for different poor-risk subtypes has not been fully analyzed. This retrospective analysis was performed to investigate whether allogeneic hematopoietic stem cell transplantation performed in first complete remission in patients with monosomal karyotype can overcome the adverse prognosis associated with these patients. Of the 4635 patients included in the study, 189 (4%) harbored a monosomal karyotype. The presence of a monosomal karyotype was associated with a worse outcome, with an inferior leukemia-free survival and overall survival (5-year leukemia-free survival and overall survival: 24 ± 3% and 26 ± 3% vs. 53 ± 1% and 57 ± 1% in monosomal-karyotype and non-monosomal-karyotype, respectively; P<0.0001) and higher relapse risk after transplantation (cumulative incidence of relapse at 5 years: 56 ± 4% in monosomal-karyotype vs. 28 ± 1% in non-monosomal-karyotype; P<0.0001). The adverse negative impact of monosomal karyotype cytogenetics was confirmed in the entire cohort in a multivariate analysis [Hazard Ratio (HR): 1.88, 95% Confidence Interval (CI):1.29-2.73, P=0.001 for relapse incidence; HR:1.71, 95%CI:1.27-2.32, P<0.0001 for leukemia-free survival; HR:1.81, 95%CI:1.32-2.48, P=0.0002 for overall survival], and was independent of the presence of other poor-risk cytogenetic subtypes. In summary, monosomal karyotype arises as a strong negative prognostic feature in acute myeloid leukemia also in patients who undergo allogeneic hematopoietic stem cell transplantation in first complete remission, stressing the need to develop additional pre- and post-transplantation strategies aimed at improving overall results. Nonetheless, allogeneic hematopoietic stem cell transplantation in early phase is currently the best therapy for this very poor-risk acute myeloid leukemia subtype.

Acute myocardial ischemia in a patient with heterozygous alpha-2-plasmin inhibitor deficiency.

In this brief report we present a patient with heterozygous alpha2 plasmin inhibitor (alpha2PI) deficiency who developed atherosclerosis and myocardial ischemia in the presence of multiple classical risk factors. Management was complicated by fear of bleeding complications with the use of antiplatelet agents and serious comorbidity.The role of alpha2PI in atherosclerosis and pathological clot formation is still not clear. This case shows, however, that atherosclerosis and acute cardiovascular events can develop in patients with reduced alpha2PI levels.