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

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.

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Key information

Conditions

Myelodysplastic Syndromes Blood Protein Disorders Bone Marrow Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia Myeloid Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leuklemia, Lymphocytic, Chronic Lung Diseases Lung Diseases, Obstructive Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Organizing Pneumonia Paraproteinemias Respiratory Tract Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Txagorritxu, Vitoria-Gasteiz, Alava, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric Assessment of Health Status Scale administration

Other

Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days

Other names: Geriatric Assessment of Health Status Scale

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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Acronym: GAH

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2015
First posted: Jun 16, 2014
Registry last updated: Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed