Clinical trial NCT00740961: Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
Official title: The Vulnerable Elders Survey Study of Older Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: psychosocial effects of cancer and its treatment
cognitive/functional effects
breast cancer
colon cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care clinic

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.

Eligibility 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

Primary outcomes:
measure: Number of impaired domains on Comprehensive Geriatric Assessment (CGA)
timeFrame: at baseline and 12 months later.
measure: Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities
timeFrame: Patients are followed for 1 year for chemotherapy adherence and survival.
measure: Vulnerable Elders Survey scores
timeFrame: at baseline and 12 months later.
measure: Functional decline
timeFrame: at baseline and 12 months later.
measure: Time to death
timeFrame: Patients are followed for 1 year for chemotherapy adherence and survival.
Secondary outcomes:
measure: Scores of individual battery of tools included in the CGA
timeFrame: at baseline and 12 months later
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Mentor
country: United States
facility: UH-LUICC
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands
state: Ohio
city: South Euclid
country: United States
facility: UH-Green Road
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Cynthia Owusu, MD, MSC
role: STUDY_CHAIR
References: