Assessment Tool for Older Patients With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining the Utility of an Assessment Tool for Older Patients With Cancer

Conditions
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Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: cognitive assessment
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geriatric Assessment Tool<br> | Other: questionnaire administration<br>* Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.<br>Procedure: cognitive assessment<br>* Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.<br>Procedure: psychosocial assessment and care<br>* Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters |  | Prior to chemotherapy and within 30 days of completion of chemotherapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive/functional effects, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific