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

Multiple Myeloma Clinical Trial

— GAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164071
• Other study ID #: CEL-GAH-2011-01
• Status: Completed
• Start date: April 11, 2012
• Est. completion date: July 4, 2015

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: July 4, 2015
• Est. primary completion date: December 3, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital La Ribera	Alzira	Valencia
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Sant Joan de Deu	Espluges De Llobregat	Barcelona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Duran I Reynals	L'Hospitalet de Llobregat	Barcelona
Spain	C.H. Universitario A Coruna	La Coruna
Spain	Arnau de Vilanova	Lerida
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital U. Gregorio Maranon	Madrid
Spain	Hospital U. Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	C.H. Navarra	Pamplona	Navarra
Spain	Hospital Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario de Canarias	San Cristobal de la Laguna	Tenerife
Spain	Hospital de Donostia	San Sebastian	Guipuzcoa
Spain	Hospital Ntra. Sra. La Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital de Segovia	Segovia
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital La Fe	Valencia
Spain	Hospital Txagorritxu	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geriatric Health Assessment (GHA) Questionnaire	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