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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02164071
Acronym
GAH
Enrollment
363
Registered
2014-06-16
Start date
2012-04-11
Completion date
2015-07-04
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Haematological malignancy, Elderly, Health Status, Scale validation

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.

Interventions

OTHERGeriatric 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

Sponsors

Celgene
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Geriatric Health Assessment (GHA) QuestionnaireApproximately 2.5 yearsA 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026