Assessment Tool for Older Patients With Cancer
- Conditions
- Psychosocial Effects of Cancer and Its TreatmentCognitive/Functional EffectsUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00477958
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
- Detailed Description
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 750 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1062
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters Prior to chemotherapy and within 30 days of completion of chemotherapy.
Trial Locations
- Locations (8)
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Tower Cancer Research Foundation🇺🇸Beverly Hills, California, United States