NCT00740961

Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

The Vulnerable Elders Survey Study of Older Cancer Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-08-25
• Last updated: 2020-07-27

Locations

5 sites across 1 country: United States