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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01005693
First received: October 30, 2009
Last updated: May 14, 2013
Last verified: May 2010
  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
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: examination
Procedure: management of therapy complications

Study Type: Interventional
Study Design: 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

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         
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 Middelheim
Investigators
Principal Investigator: Dirk Schrijvers, MD, PhD Ziekenhuis Netwerk Antwerpen Middelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01005693     History of Changes
Other Study ID Numbers: ZNA-2008-FOD-GER001, CDR0000658351, EU-20985
Study First Received: October 30, 2009
Last Updated: May 14, 2013
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on April 16, 2014