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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01005693
• Other study ID #: ZNA-2008-FOD-GER001
• Secondary ID: CDR0000658351EU-
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2009
• Last updated: May 14, 2013
• Start date: October 2009

Study information

• Verified date: May 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• questionnaire administration

Procedure:
• cognitive assessment

• examination

• management of therapy complications

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerpen
Belgium	Ziekenhuis Netwerk Antwerpen Stuivenberg	Antwerpen
Belgium	Virga Jesse Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Netwerk Antwerpen (ZNA)

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer			No
Primary	Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)			No
Primary	Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC			No