- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00416481
Assessing Older Patients With Cancer
Development of a Geriatric Assessment Measure for Older Patients With Cancer
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
- Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
- Determine the length of time necessary to complete the geriatric assessment.
- Determine the variance and number of missing items.
- Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
- 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Indiana
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Howard Community Hospital
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La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, United States, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Michigan
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St. Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Nevada
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Nevada Cancer Research Foundation
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New York
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East Syracuse, New York, United States, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy at any stage
- Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit
PATIENT CHARACTERISTICS:
- Any performance status allowed
- Must be able to follow directions in English
- Sufficient cognitive and psychological function to give consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean and median time to complete the entire geriatric assessment
Time Frame: Up to 3 years
|
Up to 3 years
|
Mean number of missing items in each subscale and the distribution of missing items
Time Frame: Up to 3 years
|
Up to 3 years
|
Percentage of patients who identify a scale to be upsetting or difficult to understand
Time Frame: Up to 3 years
|
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
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Alice B. Kornblith, PhD, Dana-Farber Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CALGB-360401
- CDR0000523527 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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