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

Completed

• Conditions: Multiple Myeloma; Leuklemia, Lymphocytic, Chronic; Myelodysplastic Syndromes; Leukemia Myeloid Acute
• Interventions: Other: Geriatric Assessment of Health Status Scale administration

• Registration Number: NCT02164071
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Primary Completion: 2013-12-03
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Completion: 2015-07-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma (MM)	Geriatric Assessment of Health Status Scale administration	Patients with Myltiple Myeloma, symptomatic or asymptomatic
Myelodysplastic Syndromes or Acute Myeloid Leukemia	Geriatric Assessment of Health Status Scale administration	Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)
Chronic Lymphocytic Leukemia (CLL)	Geriatric Assessment of Health Status Scale administration	Patients with Chronic Lymphocytic Leukemia

Primary Outcome Measures

Name	Time	Method
Geriatric Health Assessment (GHA) Questionnaire	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.

Trial Locations

Locations (22)

Hospital Txagorritxu; 🇪🇸 Vitoria, Alava, Spain

Hospital Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Donostia; 🇪🇸 San Sebastian, Guipuzcoa, Spain

Hospital U. Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Spain

C.H. Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario de Canarias; 🇪🇸 San Cristobal de la Laguna, Tenerife, Spain

Hospital Ntra. Sra. La Candelaria; 🇪🇸 Santa Cruz de Tenerife, Tenerife, Spain

Hospital La Ribera; 🇪🇸 Alzira, Valencia, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

C.H. Universitario A Coruna; 🇪🇸 La Coruna, Spain

Arnau de Vilanova; 🇪🇸 Lerida, Spain

Hospital U. Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital de Segovia; 🇪🇸 Segovia, Spain

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Sant Joan de Deu; 🇪🇸 Espluges De Llobregat, Barcelona, Spain

Hospital Duran I Reynals; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain