Determining the Utility of an Assessment Tool for Older Patients With Cancer
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool
Prior to chemotherapy and within 30 days of completion of chemotherapy.
Yes
Arti Hurria, MD
Principal Investigator
Beckman Research Institute
United States: Institutional Review Board
06170
NCT00477958
January 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |