Clinical trial NCT02164071: Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
Official title: Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Leukemia Myeloid Acute
Multiple Myeloma
Leuklemia, Lymphocytic, Chronic
Keywords: Haematological malignancy
Elderly
Health Status
Scale validation
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 363
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: Geriatric Health Assessment (GHA) Questionnaire
timeFrame: Approximately 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
state: Alava
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Espluges De Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran I Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Majadahonda
country: Spain
facility: Hospital U. Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: C.H. Navarra
state: Navarra
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Ntra. Sra. La Candelaria
state: Tenerife
city: Alzira
country: Spain
facility: Hospital La Ribera
state: Valencia
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: La Coruna
country: Spain
facility: C.H. Universitario A Coruna
city: Lerida
country: Spain
facility: Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital U. Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Segovia
country: Spain
facility: Hospital de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Celgene
name: Jose Luis Garcia, PhD
role: STUDY_DIRECTOR
References: