Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer.

PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.

Secondary

• Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.

OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.

Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).

Patients then begin planned chemotherapy.

After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed cancer

• Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen

PATIENT CHARACTERISTICS:

• Must be able to understand English

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior enrollment in this trial

• No concurrent enrollment on a phase I clinical trial

Trial Contact Information

Trial Lead Organizations/Sponsors

City of Hope Comprehensive Cancer Center

Arti Hurria

Principal Investigator

U.S.A.
California
	Beverly Hills
	Tower Cancer Research Foundation
		Robert W. Decker, MD	Ph: 310-888-8680
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Cen	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Cent	Ph: 877-827-8839
			Email: ucstudy@uci.edu
Connecticut
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph: 203-785-5702
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		William P. Tew, MD	Ph: 212-639-6555
			Email: teww@mskcc.org
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Supriya Mohile, MD	Ph: 585-275-5513
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive	Ph: 336-713-6771
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph: 800-641-2422

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00477958
Information obtained from ClinicalTrials.gov on March 26, 2012

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