Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

Breast Cancer Clinical Trial

Official title:

The Vulnerable Elders Survey Study of Older Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00740961
• Other study ID #: CASE8Y07
• Status: Terminated
• Start date: March 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UH-LUICC	Mentor	Ohio
United States	UH-Chagrin Highlands	Orange Village	Ohio
United States	UH-Green Road	South Euclid	Ohio
United States	UH-Westlake	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of impaired domains on Comprehensive Geriatric Assessment (CGA)		at baseline and 12 months later.
Primary	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.
Primary	Vulnerable Elders Survey scores		at baseline and 12 months later.
Primary	Functional decline		at baseline and 12 months later.
Primary	Time to death		Patients are followed for 1 year for chemotherapy adherence and survival.
Secondary	Scores of individual battery of tools included in the CGA		at baseline and 12 months later