Assessment Tool for Older Patients With Cancer
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About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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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 design
Primary purpose
Allocation
Interventional model
Masking
1,062 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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