Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. There is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (QOF) and correlate them to the prognostic.

Official Title
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Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Conditions
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Stem Cell Transplant

Intervention / Treatment
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* Other: Comprehensive geriatric assessment (CGA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years or more at time of transplantation Acute leukemia Myelodysplastic syndrome Myeloproliferative neoplasm Exclusion Criteria: Patient opposed to the protocol Vulnerable patients protected by curatorship or administrative supervision

Ages Eligible for Study
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Minimum Age: 60 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Comprehensive geriatric assessment (CGA)|Questionnaires on nutritional status, autonomy and quality of life|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | at one year post allogeneic hematopoietic stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | at two years post allogeneic hematopoietic stem cell transplantation | 
| Morbidity Index |  | at one year | 
| Morbidity Index |  | at two years | 
| Survival without disease and chronic graft-versus-host disease |  | at one year post allogeneic hematopoietic stem cell transplantation | 
| Survival without disease and chronic graft-versus-host disease |  | at two years post allogeneic hematopoietic stem cell transplantation | 
| Proportion of patient with Viral Reactivation | Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus | at one year | 
| Acute graft-versus-host disease |  | at 100 days | 
| Chronic graft-versus-host disease |  | at 1 year | 
| Chronic graft-versus-host disease |  | at 2 years | 
| Incidence of relapse |  | at two years | 
| Walk test | Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions. | at day 100 | 
| Walk test | Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions. | at one year | 
| Walk test | Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions. | at two years | 
| Nutritional score | Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual. | at day 100 | 
| Nutritional score | Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual. | at one year | 
| Nutritional score | Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual. | at two years | 
| Karnofsky index | The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health) | at day 100 | 
| Karnofsky index | The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health) | at one year | 
| Evaluation of autonomy | Autonomy will be evaluated using ADL and IADL score. Instrumental activities of daily living - global score range from 0 to 4. | at one year | 
| Evaluation of Quality of life | Quality of life evaluated using questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems. EORTC QLQ-C30 Scoring Manual. Fayers PM et al. on behalf of the EORTC Quality of Life Group. EORTC, 2001. ISBN: 2-9300. | at one year | 
| Length of hospitalisation |  | at two years |