Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
psychosocial effects of cancer and its treatment, cognitive/functional effects, breast cancer, colon cancer
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.
Detailed description
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.
Interventions
BEHAVIORALcompliance 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.
DRUGsystemic chemotherapy
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
OTHERmedical 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.
OTHERstudy 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.
OTHERsurvey 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.
PROCEDUREcognitive 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.
PROCEDUREpsychosocial 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.
Sponsors
Case Comprehensive Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Scores of individual battery of tools included in the CGA | at baseline and 12 months later |
Countries
United States
Outcome results
None listed