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Status unknownNCT01005693Updated May 15, 2013

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

An interventional study of questionnaire administration and cognitive assessment in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Ziekenhuis Netwerk Antwerpen (ZNA). Status unknown at 4 sites in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-05-15.

Sponsored by Ziekenhuis Netwerk Antwerpen (ZNA) · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

Ziekenhuis Netwerk Antwerpen (ZNA) is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Enrollment
300 participants (estimated)

Interventions

  • Otherquestionnaire administration
  • Procedurecognitive assessment
  • Procedureexamination
  • Proceduremanagement of therapy complications
06

What researchers measure

Primary outcomes

  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

07

Study locations

4 of 4 sites recruiting
  • Onze Lieve Vrouw Ziekenhuis Aalst
    Aalst, B-9300, Belgium
    • Contact Person · Contact
    Recruiting
  • Ziekenhuis Netwerk Antwerpen Middelheim
    Antwerpen, B-2020, Belgium
    • Contact Person · Contact · 32-3-280-2339
    Recruiting
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
    Antwerpen, B-2060, Belgium
    • Contact Person · Contact
    Recruiting
  • Virga Jesse Hospital
    Hasselt, 3500, Belgium
    • Contact Person · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01005693
Lead sponsor
Ziekenhuis Netwerk Antwerpen (ZNA)
First posted
Nov 1, 2009
Start date
Oct 2009
Primary completion
Oct 2011 (estimated)
Last update
May 15, 2013

Study contacts

Dirk Schrijvers, MD, PhD
principal investigator · Ziekenhuis Netwerk Antwerpen (ZNA)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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