Assessment Tool for Older Patients With Cancer
RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer.
PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: psychosocial assessment and care
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Determining the Utility of an Assessment Tool for Older Patients With Cancer|
- Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool [ Time Frame: Prior to chemotherapy and within 30 days of completion of chemotherapy. ] [ Designated as safety issue: Yes ]
- Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters [ Time Frame: Prior to chemotherapy and within 30 days of completion of chemotherapy. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Experimental: Geriatric Assessment Tool||
Other: questionnaire administration
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.Procedure: cognitive assessment
Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.Procedure: psychosocial assessment and care
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
- Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.
- Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.
OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. 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 chemotherapy.
After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477958
|United States, California|
|Tower Cancer Research Foundation||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Robert W. Decker, MD 310-888-8680|
|City of Hope Comprehensive Cancer Center||Recruiting|
|Duarte, California, United States, 91010-3000|
|Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-827-8839 firstname.lastname@example.org|
|United States, Connecticut|
|Yale Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06520-8028|
|Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: William P. Tew, MD 212-639-6555 email@example.com|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Supriya Mohile, MD 585-275-5513|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771|
|United States, Ohio|
|Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422|
|Principal Investigator:||Arti Hurria, MD||Beckman Research Institute|