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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02164071
Collaborator
(none)
363
Enrollment
22
Locations
38.7
Actual Duration (Months)
16.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Geriatric Assessment of Health Status Scale administration

Study Design

Study Type:
Observational
Actual Enrollment :
363 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
Actual Study Start Date :
Apr 11, 2012
Actual Primary Completion Date :
Dec 3, 2013
Actual Study Completion Date :
Jul 4, 2015

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Txagorritxu Vitoria Alava Spain 01009
    2 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33006
    3 Hospital Sant Joan de Deu Espluges De Llobregat Barcelona Spain 08950
    4 Hospital Duran I Reynals L'Hospitalet de Llobregat Barcelona Spain 08908
    5 Hospital Parc Tauli Sabadell Barcelona Spain 08208
    6 Hospital de Donostia San Sebastian Guipuzcoa Spain 20080
    7 Hospital U. Puerta de Hierro Majadahonda Madrid Spain 28222
    8 C.H. Navarra Pamplona Navarra Spain 31008
    9 Hospital Universitario de Canarias San Cristobal de la Laguna Tenerife Spain 38320
    10 Hospital Ntra. Sra. La Candelaria Santa Cruz de Tenerife Tenerife Spain 38010
    11 Hospital La Ribera Alzira Valencia Spain 46600
    12 Hospital Germans Trias i Pujol Badalona Spain 08916
    13 Hospital Vall d'Hebron Barcelona Spain 08035
    14 Hospital Clinic Barcelona Spain 08036
    15 Hospital Virgen de las Nieves Granada Spain 18014
    16 C.H. Universitario A Coruna La Coruna Spain 15006
    17 Arnau de Vilanova Lerida Spain 25198
    18 Hospital U. Gregorio Maranon Madrid Spain 28007
    19 Hospital Infanta Leonor Madrid Spain 28031
    20 Hospital de Segovia Segovia Spain 40002
    21 Hospital Virgen del Rocio Sevilla Spain 41013
    22 Hospital La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Jose Luis Garcia, PhD, Celgene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT02164071
    Other Study ID Numbers:
    • CEL-GAH-2011-01
    First Posted:
    Jun 16, 2014
    Last Update Posted:
    Nov 18, 2019
    Last Verified:
    Nov 1, 2019
    Keywords provided by Celgene
    Haematological malignancy
    Elderly
    Health Status
    Scale validation
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms
    Hematologic Neoplasms
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of Nov 18, 2019