Skip to main content
Clinical Trials/NCT02164071
NCT02164071
Completed
Not Applicable

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

Celgene22 sites in 1 country363 target enrollmentApril 11, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myelodysplastic Syndromes
Sponsor
Celgene
Enrollment
363
Locations
22
Primary Endpoint
Geriatric Health Assessment (GHA) Questionnaire
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2012
End Date
July 4, 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Celgene
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (22)

Loading locations...

Similar Trials