Stem Cell Transplant
Conditions
Brief summary
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.
Interventions
Questionnaires on nutritional status, autonomy and quality of life
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years or more at time of transplantation * Patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, Myeloproliferative neoplasm) or for an Acute lymphoblastic leukemia * No opposition to participate
Exclusion criteria
* Patient opposed to the protocol * Vulnerable patients protected by curatorship or administrative supervision * Patients not covered by a social security scheme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | at one year post allogeneic hematopoietic stem cell transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity Index | at one year | — |
| Survival without disease and chronic graft-versus-host disease | at one year post allogeneic hematopoietic stem cell transplantation | — |
| Proportion of patient with Viral Reactivation | at one year | Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus |
| Acute graft-versus-host disease | at 100 days | — |
| Chronic graft-versus-host disease | at 1 year | — |
| Incidence of relapse | at two years | — |
| Walk test | at day 100 | Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions. |
| Nutritional score | at day 100 | 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. |
| Karnofsky index | at day 100 | The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health) |
| Overall survival | at two years post allogeneic hematopoietic stem cell transplantation | — |
| Evaluation of Quality of life | at one year | 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. |
| Length of hospitalisation initially | at two years | — |
| Length of hospitalisation during the first year after graft | Up to one year | — |
| Questionnaire completion rate | At 2 years | — |
| Length of pre-grafting visit | At 2 years | — |
| Length of D100 visit | At 2 years | — |
| Length of 1year visit | At 2 years | — |
| Length of 2 years visit | At 2 years | — |
| Evaluation of autonomy | at one year | Autonomy will be evaluated using ADL and IADL score. Instrumental activities of daily living - global score range from 0 to 4. |
Countries
France
Outcome results
None listed