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

NCT ID: NCT02164071

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-11

Study Completion Date

2015-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Myeloma (MM)

Patients with Myltiple Myeloma, symptomatic or asymptomatic

Geriatric Assessment of Health Status Scale administration

Intervention Type OTHER

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

Myelodysplastic Syndromes or Acute Myeloid Leukemia

Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)

Geriatric Assessment of Health Status Scale administration

Intervention Type OTHER

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

Chronic Lymphocytic Leukemia (CLL)

Patients with Chronic Lymphocytic Leukemia

Geriatric Assessment of Health Status Scale administration

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Geriatric Assessment of Health Status Scale

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Luis Garcia, PhD

Role: STUDY_DIRECTOR

Celgene

Locations

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Hospital Txagorritxu

Vitoria-Gasteiz, Alava, Spain

Site Status

Hospital Sant Joan de Deu

Espluges de Llobregat, Barcelona, Spain

Site Status

Hospital Duran I Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital U. Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

C.H. Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Site Status

Hospital Ntra. Sra. La Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Hospital La Ribera

Alzira, Valencia, Spain

Site Status

C.H. Universitario A Coruna

A Coruña, , Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Hospital Virgen de las Nieves

Granada, , Spain

Site Status

Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital U. Gregorio Maranon

Madrid, , Spain

Site Status

Hospital Infanta Leonor

Madrid, , Spain

Site Status

Hospital de Segovia

Segovia, , Spain

Site Status

Hospital Virgen del Rocio

Seville, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CEL-GAH-2011-01

Identifier Type: -

Identifier Source: org_study_id

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