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Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005693
Recruitment Status : Unknown
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 2, 2009
Last Update Posted : May 15, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Other: questionnaire administration Procedure: cognitive assessment Procedure: examination Procedure: management of therapy complications Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Primary Purpose: 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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2011

Primary Outcome Measures :
  1. Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
  2. Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)
  3. Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005693

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Onze Lieve Vrouw Ziekenhuis Aalst Recruiting
Aalst, Belgium, B-9300
Contact: Contact Person         
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         
Virga Jesse Hospital Recruiting
Hasselt, Belgium, 3500
Contact: Contact Person         
Sponsors and Collaborators
Ziekenhuis Netwerk Antwerpen (ZNA)
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Principal Investigator: Dirk Schrijvers, MD, PhD Ziekenhuis Netwerk Antwerpen (ZNA)

Layout table for additonal information Identifier: NCT01005693     History of Changes
Other Study ID Numbers: ZNA-2008-FOD-GER001
CDR0000658351 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2010

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific