NCT Number: NCT00416481
Assessing 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.
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Notify MeKey information
Age range
65 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Elkhart General Hospital, Elkhart, Indiana, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Mean and median time to complete the entire geriatric assessment
Time frame: Up to 3 years
-
Mean number of missing items in each subscale and the distribution of missing items
Time frame: Up to 3 years
-
Percentage of patients who identify a scale to be upsetting or difficult to understand
Time frame: 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
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Development of a Geriatric Assessment Measure for Older Patients With Cancer
Important dates
- Study start
- 2006
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Dec 28, 2006
- Registry last updated
- Jul 13, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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