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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00740961
Other study ID # CASE8Y07
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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