Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00740961

Purpose

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	Intervention
Breast Cancer Cancer-Related Problem/Condition Colorectal Cancer	Procedure: cognitive assessment Procedure: compliance monitoring Procedure: medical chart review Procedure: psychosocial assessment and care Procedure: study of socioeconomic and demographic variables Procedure: survey administration Procedure: systemic chemotherapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Vulnerable Elders Survey Study of Older Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number of impaired domains on Comprehensive Geriatric Assessment (CGA) [ Designated as safety issue: No ]
Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities [ Designated as safety issue: No ]
Vulnerable Elders Survey scores [ Designated as safety issue: No ]
Functional decline [ Designated as safety issue: No ]
Time to death [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores of individual battery of tools included in the CGA [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740961

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Cynthia Owusu, MD, MSC

Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593931, CASE-8Y07
Study First Received:	August 22, 2008
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00740961
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/treatment
cognitive/functional effects
breast cancer
colon cancer

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Breast Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Breast Diseases
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009