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

November 14, 2019 updated by: Celgene

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • La Coruna, Spain, 15006
        • C.H. Universitario A Coruña
      • Lerida, Spain, 25198
        • Arnau de Vilanova
      • Madrid, Spain, 28007
        • Hospital U. Gregorio Marañón
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor
      • Segovia, Spain, 40002
        • Hospital de Segovia
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital la Fe
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Hospital Txagorritxu
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Espluges De Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran I Reynals
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital U. Puerta de Hierro
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • C.H. Navarra
    • Tenerife
      • San Cristobal de la Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Ntra. Sra. La Candelaria
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Hospital La Ribera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients, even being naïve to treatment, are eligible to receive treatment at any time as per clinical practice. Patients ≥ 65 years old, newly diagnosed, naïve to treatment, belonging to one of the 3 following groups. 1.- Patients with Myelodysplastic Syndromes (any risk according to) or Acute myeloid leukemia; 2.- Patients with Multiple Myeloma, either symptomatic or asymptomatic; or 3.- Patients with Chronic lymphocytic leukemia (including stadium A).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Myeloma (MM)
Patients with Myltiple Myeloma, symptomatic or asymptomatic
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
Other Names:
  • Geriatric Assessment of Health Status Scale
Myelodysplastic Syndromes or Acute Myeloid Leukemia
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
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
Chronic Lymphocytic Leukemia (CLL)
Patients with Chronic Lymphocytic Leukemia
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
Other Names:
  • Geriatric Assessment of Health Status Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Jose Luis Garcia, PhD, Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2012

Primary Completion (Actual)

December 3, 2013

Study Completion (Actual)

July 4, 2015

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL-GAH-2011-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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