Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
93 participants
OBSERVATIONAL
2006-12-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying ways to assess older patients with cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment Tool for Older Patients With Cancer
NCT00477958
Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
NCT03902535
Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment
NCT01005693
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
NCT02517034
Assessment of Older Adults With Cancer: Feasibility of Computer Survey Methodology
NCT00977834
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
quality of life questionnaires
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
quality of life questionnaires
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alice B. Kornblith, PhD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, Schmieder L, Ansari R, Tew WP, Weckstein D, Kirshner J, Togawa K, Hansen K, Katheria V, Stone R, Galinsky I, Postiglione J, Cohen HJ. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985. Epub 2011 Feb 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALGB-360401
Identifier Type: -
Identifier Source: secondary_id
CDR0000523527
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-360401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.