Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies

Study Overview
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Brief Summary
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The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies. Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making. The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively. If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.

Official Title
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Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies

Conditions
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Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leuklemia, Lymphocytic, Chronic

Intervention / Treatment
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* Other: Geriatric Assessment of Health Status Scale administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 65 years old. Treatment-naïve patients Newly diagnosed patients who belong to one of the 3 following groups: Patients with MDS (any risk grade as per IPSS) or AML Patients with multiple myeloma (symptomatic or not) or Patients with chronic lymphocytic leukemia (including A status) Patients who have granted their informed consent. Exclusion Criteria: Not fulfilling selection criteria

Ages Eligible for Study
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Minimum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Myeloma (MM)<br>Patients with Myltiple Myeloma, symptomatic or asymptomatic | Other: Geriatric Assessment of Health Status Scale administration<br>* Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days<br>* Other names: Geriatric Assessment of Health Status Scale;|
| Myelodysplastic Syndromes or Acute Myeloid Leukemia<br>Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML) | Other: Geriatric Assessment of Health Status Scale administration<br>* Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days<br>* Other names: Geriatric Assessment of Health Status Scale;|
| Chronic Lymphocytic Leukemia (CLL)<br>Patients with Chronic Lymphocytic Leukemia | Other: Geriatric Assessment of Health Status Scale administration<br>* Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days<br>* Other names: Geriatric Assessment of Health Status Scale;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Health Assessment (GHA) Questionnaire | A composite variable comprised of all the dimensions that make up the GHA questionnaire will be obtained on stable patients as a result of the implementation of a questionnaire by two independent evaluators: one investigator and one duly trained health professional. | Approximately 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haematological malignancy, Elderly, Health Status, Scale validation