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Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2009
First Received: October 30, 2009   No Changes Posted
Sponsor: Ziekenhuis Netwerk Antwerpen Middelheim
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01005693
  Purpose

RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.

PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.


Condition Intervention
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Unspecified Adult Solid Tumor, Protocol Specific
Drug: chemotherapy
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: examination
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Supportive Care
Official Title: Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer [ Designated as safety issue: No ]
  • Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA) [ Designated as safety issue: No ]
  • Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To assess the feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.
  • To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).
  • To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.
  • To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.

OUTLINE: This is a multicenter study.

All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.

  • Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.
  • Group 2 (vulnerable): Patients receive specialized care and individualized treatment.
  • Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.

Patients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cancer

    • Undergoing out-patient care
    • Planning to undergo primary chemotherapeutic treatment or treatment with targeted agents for curative or palliative intent
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • Able to understand the Flemish language, give informed consent, and be followed at the investigational site
  • Must be considered eligible for trial participation by the Investigator
  • No severe known dementia
  • No pre-existing major neurological or psychiatric problems
  • No refusal of the standard anticancer strategy as defined by the service instruction book

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005693

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst Recruiting
Aalst, Belgium, B-9300
Contact: Contact Person     Not Available        
Virga Jesse Hospital Recruiting
Hasselt, Belgium, 3500
Contact: Contact Person     Not Available        
Ziekenhuis Netwerk Antwerpen Middelheim Recruiting
Antwerpen, Belgium, B-2020
Contact: Contact Person     32-3-280-2339        
Ziekenhuis Netwerk Antwerpen Stuivenberg Recruiting
Antwerpen, Belgium, B-2060
Contact: Contact Person     Not Available        
Sponsors and Collaborators
Ziekenhuis Netwerk Antwerpen Middelheim
Investigators
Principal Investigator: Dirk Schrijvers, MD, PhD Ziekenhuis Netwerk Antwerpen Middelheim
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000658351, ZNA-2008-FOD-GER001, EU-20985
Study First Received: October 30, 2009
Last Updated: October 30, 2009
ClinicalTrials.gov Identifier: NCT01005693     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:
Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Pathologic Processes
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Myelodysplastic-Myeloproliferative Diseases
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on February 08, 2010