Clinical trial NCT01005693: Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
measure: Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)
measure: Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Middelheim
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Hasselt
country: Belgium
facility: Virga Jesse Hospital
Study officials:
affiliation: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Dirk Schrijvers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: