Assessing Older Patients With Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying ways to assess older patients with cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
Primary
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Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
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Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
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Determine the length of time necessary to complete the geriatric assessment.
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Determine the variance and number of missing items.
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Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
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Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status.
Secondary
- Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status.
OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over).
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. 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 treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient assessment Patients undergo assessments of cognition and performance status using the healthcare professional-rated Karnofsky performance scale. 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 self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support. Patients then begin planned treatment. |
Behavioral: quality of life questionnaires
|
Outcome Measures
Primary Outcome Measures
- Mean and median time to complete the entire geriatric assessment [Up to 3 years]
- Mean number of missing items in each subscale and the distribution of missing items [Up to 3 years]
- Percentage of patients who identify a scale to be upsetting or difficult to understand [Up to 3 years]
- Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completed [Up to 3 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignancy at any stage
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Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit
PATIENT CHARACTERISTICS:
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Any performance status allowed
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Must be able to follow directions in English
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Sufficient cognitive and psychological function to give consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 2 | Howard Community Hospital | Kokomo | Indiana | United States | 46904 |
| 3 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
| 4 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
| 5 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 6 | Michiana Hematology-Oncology, PC - South Bend | South Bend | Indiana | United States | 46601 |
| 7 | Saint Joseph Regional Medical Center | South Bend | Indiana | United States | 46617 |
| 8 | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan | United States | 49085 |
| 9 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 10 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 11 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
| 12 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 13 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Alice B. Kornblith, PhD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-360401
- CALGB-360401
- CDR0000523527