Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

Case Comprehensive Cancer Center (Case CCC)

Status

Terminated

Conditions

Breast Cancer

Psychosocial Effects of Cancer and Its Treatment

Cognitive/Functional Effects

Colorectal Cancer

Treatments

Other: study of socioeconomic and demographic variables

Other: survey administration

Procedure: cognitive assessment

Other: medical chart review

Behavioral: compliance monitoring

Procedure: psychosocial assessment and care

Drug: systemic chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT00740961

CASE8Y07

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

63 participants in 2 patient groups

Patients with cancer

Description:

Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.

Treatment: