Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
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Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
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Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
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Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
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Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.
OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients are followed for 1 year for chemotherapy adherence and survival.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with cancer Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes. |
Behavioral: compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Drug: systemic chemotherapy
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
Other: medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
Other: study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
|
| Patients without cancer non-cancer patients, seeking care at out-patient clinics |
Behavioral: compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
Other: study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Other: survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Procedure: psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
|
Outcome Measures
Primary Outcome Measures
- Number of impaired domains on Comprehensive Geriatric Assessment (CGA) [at baseline and 12 months later.]
- Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities [Patients are followed for 1 year for chemotherapy adherence and survival.]
- Vulnerable Elders Survey scores [at baseline and 12 months later.]
- Functional decline [at baseline and 12 months later.]
- Time to death [Patients are followed for 1 year for chemotherapy adherence and survival.]
Secondary Outcome Measures
- Scores of individual battery of tools included in the CGA [at baseline and 12 months later]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed breast or colon cancer
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Newly diagnosed disease
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Any stage disease
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Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site
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Scheduled to start a new chemotherapy regimen (objective II only)
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Not concurrently enrolled in a GEM trial (objectives II, III, and IV)
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Hormone receptor status not specified
PATIENT CHARACTERISTICS:
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Understands English
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Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Diseases Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106 |
| 2 | UH-LUICC | Mentor | Ohio | United States | 44060 |
| 3 | UH-Chagrin Highlands | Orange Village | Ohio | United States | 44122 |
| 4 | UH-Green Road | South Euclid | Ohio | United States | 44121 |
| 5 | UH-Westlake | Westlake | Ohio | United States | 44145 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Study Chair: Cynthia Owusu, MD, MSC, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE8Y07