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

Not Applicable

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT01005693
• Lead Sponsor: Ziekenhuis Netwerk Antwerpen (ZNA)

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.

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Status Verified: 2010-05
• Primary Completion: 2011-10
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Onze Lieve Vrouw Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Ziekenhuis Netwerk Antwerpen Middelheim; 🇧🇪 Antwerpen, Belgium

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

Ziekenhuis Netwerk Antwerpen Stuivenberg; 🇧🇪 Antwerpen, Belgium