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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00477958 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cognitive/Functional Effects 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 Type: | Interventional |
| 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 500 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| 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 becomingapatient@coh.org | |
| 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 ucstudy@uci.edu | |
| 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 teww@mskcc.org | |
| 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 |
More Information
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00477958 History of Changes |
| Other Study ID Numbers: | 06170, P30CA033572, CHNMC-06170, MSKCC-06034, CDR0000540332 |
| Study First Received: | May 23, 2007 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
cognitive/functional effects psychosocial effects of cancer and its treatment unspecified adult solid tumor, protocol specific |