Assessment Tool for Older Patients With Cancer
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 [Prior to chemotherapy and within 30 days of completion of chemotherapy.]
Secondary Outcome Measures
- Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters [Prior to chemotherapy and within 30 days of completion of chemotherapy.]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Pathologically confirmed cancer
-
Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen
PATIENT CHARACTERISTICS:
- Must be able to understand English
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
-
No prior enrollment in this trial
-
No concurrent enrollment on a phase I clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tower Cancer Research Foundation | Beverly Hills | California | United States | 90211 |
| 2 | City of Hope Medical Center | Duarte | California | United States | 91010-3000 |
| 3 | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | United States | 92868 |
| 4 | Yale Cancer Center | New Haven | Connecticut | United States | 06520-8028 |
| 5 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 6 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 7 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 8 | Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Arti Hurria, MD, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06170
- P30CA033572
- CHNMC-06170
- MSKCC-06034
- CDR0000540332