NCT01005693

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

October 30, 2009

Last Update Submit

May 14, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

  • Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer

  • Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)

  • Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC

Interventions

questionnaire administrationOTHER
cognitive assessmentPROCEDURE
examinationPROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

RECRUITING

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

RECRUITING

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, B-2060, Belgium

RECRUITING

Virga Jesse Hospital

Hasselt, 3500, Belgium

RECRUITING

MeSH Terms

Interventions

Mental Status and Dementia TestsRestraint, Physical

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Dirk Schrijvers, MD, PhD

    Ziekenhuis Netwerk Antwerpen (ZNA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Last Updated

May 15, 2013

Record last verified: 2010-05

Locations

BE(4)