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Trial record 1 of 1 for:    NCT00416481
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Assessing Older Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00416481
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: quality of life questionnaires

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 Design
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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Geriatric Assessment Measure for Older Patients With Cancer
Study Start Date : December 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Groups and Cohorts
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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.

 Behavioral: quality of life questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. Mean and median time to complete the entire geriatric assessment [ Time Frame: Up to 3 years ]
  2. Mean number of missing items in each subscale and the distribution of missing items [ Time Frame: Up to 3 years ]
  3. Percentage of patients who identify a scale to be upsetting or difficult to understand [ Time Frame: Up to 3 years ]
  4. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 65 years and older with a histologically confirmed malignancy enrolled on any cooperative group-sponsored cancer treatment trial.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416481


Locations
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United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
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
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Study Chair: Alice B. Kornblith, PhD Dana-Farber Cancer Institute
More Information
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Publications of Results:

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00416481    
Other Study ID Numbers: CALGB-360401
CALGB-360401
CDR0000523527 ( Registry Identifier: NCI Physician Data Query )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific