Psychosocial Evaluation Prior to Lung Transplantation

Study Overview
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Brief Summary
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In a prospective longitudinal cohort study we aim at investigating the extent to which pre-transplant psychosocial levels of functioning predict the medical and psychosocial outcomes of lung transplantation. There is evidence that e.g. persistently elevated depressive symptoms are associated with reduced survival after lung transplantation

Detailed Description
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There is ample evidence that there are high rates of anxiety and depression among patients with end-stage lung disease. In addition, psychological dysfunction and distress seem to be especially prevalent in patients awaiting lung transplantation. Even though patients benefit from the transplant procedure with respect to long-term health-related quality of life (HRQoL), they also face significant challenges in terms of psychosocial adjustment after the transplantation. There is evidence that e.g. persistently elevated depressive symptoms are associated with reduced survival after lung transplantation. Currently, the screening process to help select among candidates for organ transplant typically involves considering a variety of psychosocial factors. However, it remains somewhat unclear which criteria are considered important in these evaluations, how differences in various aspects of psychosocial functioning are weighed in making the ultimate decision on the suitability of a patient for transplantation, and the extent to which pretransplant psychosocial characteristics predict the medical and psychosocial outcomes of the procedure. Standardized psychometric instruments with proven reliability and validity can prevent the danger of personal bias in the selection of candidates for transplantation. In addition, structured psychometric instruments can help to identify patients with multiple care needs and can support the development of psychosocial interventions designed to increase quality of life and to decrease the risk of a less favorable transplant outcome through modifying the factors that might place patients at risk. In a longitudinal prospective cohort study, psychosocial functioning will be assessed at multiple time points both before and after lung transplantation. Assessment of psychosocial functioning will be conducted using a validated, structured interview which allows a comprehensive evaluation of the level of adjustment in 10 aspects of psychosocial functioning - the Transplant Evaluation Rating Scale (TERS) - and standardized self-report instruments. The TERS has shown to be an important and significant predictor of several facets of somatic and psychosocial outcomes e.g. in patients after liver transplantation, left ventricular assist device implantation, and hematopoietic stem cell transplantation. For each patient, a face-to-face psychosomatic evaluation 1 year after Transplantation will take place during a routine clinical assessments at the Department of Respiratory Medicine. The following outcome parameters will be assessed: Mental disorders (current) Psychological processing of lung transplantation (including organ integration and the patient's relationship with the donor, chronic stress/psychological distress and the emotional effects of transplantation/immunosuppression Return to work one year after lung transplantation Psychological interventions during the first postoperative year Intake of (new) psychotropic medication during the first postoperative year

Official Title
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Standardized Evaluation of Psychosocial Functioning in Patients Awaiting Lung Transplantation

Conditions
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Lung Transplantation, Psychosomatic Medicine

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients listed for lung Transplantation (including combined Transplantation) or who are evaluated at the interdisciplinary lung transplant outpatient clinic regular post-transplant visits at the Department of Respiratory Medicine informed consent Exclusion Criteria: Age below 18 years lacking German language skills severe cognitive disability re-do Transplantation colonization with pan- or multi-resistant organisms with Need for isolation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in survival status after lung transplantation | number of days survived during first post-operative year | assessments at 1, 3, 6 and 12 month after lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospitalization after lung transplantation | number of days of hospitalization during first post-operative year | assessments at 1, 3, 6 and 12 month after lung transplantation | 
| change in adherence during the first post-operative year | mean composite adherence score to immunosuppressants (IS) based on multiple clinical ratings and IS trough levels during first post-operative year | assessments at 1, 3, 6 and 12 month after lung transplantation | 
| change from baseline quality of life to one year post-transplantation | Change in self-rated multidimensional quality of life | once before admission to waiting list and 12 month after lung transplantation | 
| change in quality of life during first post-operative year | mean self-rated multidimensional quality of life based on multiple assessments during first post-operative year | 1, 3, 6 and 12 month after lung transplantation | 
| change from baseline psychological distress (questionnaire) to one year post-transplantation | change in levels of self-rated anxiety and depressive symptoms | once before admission to waiting list and 12 month after lung transplantation | 
| change in psychological distress (questionnaire) during first post-operative year | mean levels of self-rated anxiety and depressive symptoms based on multiple assessments during first post-operative year | 1, 3, 6 and 12 month after lung transplantation | 
| mental disorders | number and kind of current mental disorders at one year after lung transplantation | 12 month after lung transplantation | 
| integration of transplant in own Body Image (questionnaire) | Quality of psychological processing of lung Transplantation and Feelings towards donor one year after lung transplantation | 12 month after lung transplantation | 
| psychological interventions | number and kind of psychosocial interventions during first post-operative year | 12 month after lung transplantation | 
| psychotropic medication | kind and intake of (new) psychotropic medication during first post-operative year | 12 month after lung transplantation | 
| change from baseline comorbidity to one year post-Transplantation (clinical Rating) | change in kind, number and degree of comorbid conditions | once before admission to waiting list and 12 month after lung transplantation | 
| Change in comorbidity (clinical Rating) | mean number and degree of comorbid conditions during first post-operative year | 1, 3, 6 and 12 month after lung transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung transplantation, psychosocial functioning, longitudinal, TERS, adherence, Quality of life