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
65 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Outcome Measure:
Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
Safety Issue:
No
Principal Investigator
Dirk Schrijvers, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ziekenhuis Netwerk Antwerpen Middelheim
Authority:
Unspecified
Study ID:
ZNA-2008-FOD-GER001
NCT ID:
NCT01005693
Start Date:
October 2009
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|
