Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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. Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients. 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. 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.

Official Title
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The Vulnerable Elders Survey Study of Older Cancer Patients

Conditions
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Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Behavioral: compliance monitoring
* Drug: systemic chemotherapy
* Other: medical chart review
* Other: study of socioeconomic and demographic variables
* Other: survey administration
* Procedure: cognitive assessment
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast or colon cancer Newly diagnosed disease Any stage disease Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site Scheduled to start a new chemotherapy regimen (objective II only) Not concurrently enrolled in a GEM trial (objectives II, III, and IV) Hormone receptor status not specified PATIENT CHARACTERISTICS: Understands English Menopausal status not specified PRIOR CONCURRENT THERAPY: See Diseases Characteristics

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cancer<br>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<br>* 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.<br>Drug: systemic chemotherapy<br>* Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer<br>Other: medical chart review<br>* A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.<br>Other: study of socioeconomic and demographic variables<br>* 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.<br>Other: survey administration<br>* 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.<br>Procedure: cognitive assessment<br>* 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.<br>Procedure: psychosocial assessment and care<br>* 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.<br>|
| Patients without cancer<br>non-cancer patients, seeking care at out-patient clinics | Behavioral: compliance monitoring<br>* 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.<br>Other: medical chart review<br>* A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.<br>Other: study of socioeconomic and demographic variables<br>* 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.<br>Other: survey administration<br>* 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.<br>Procedure: cognitive assessment<br>* 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.<br>Procedure: psychosocial assessment and care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of individual battery of tools included in the CGA |  | at baseline and 12 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, cognitive/functional effects, breast cancer, colon cancer