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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 3, 2013

Interventions

  • Other: Geriatric Assessment of Health Status Scale administration
    • Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days

Arms, Groups and Cohorts

  • Multiple Myeloma (MM)
    • Patients with Myltiple Myeloma, symptomatic or asymptomatic
  • Myelodysplastic Syndromes or Acute Myeloid Leukemia
    • Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)
  • Chronic Lymphocytic Leukemia (CLL)
    • Patients with Chronic Lymphocytic Leukemia

Clinical Trial Outcome Measures

Primary Measures

  • Geriatric Health Assessment (GHA) Questionnaire
    • Time Frame: Approximately 2.5 years
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Celgene
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jose Luis Garcia, PhD, Study Director, Celgene

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