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

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 Cognitive/Functional Effects Colorectal Cancer Psychosocial Effects of Cancer and Its Treatment	Behavioral: compliance monitoring Drug: systemic chemotherapy Other: medical chart review Other: study of socioeconomic and demographic variables Other: survey administration Procedure: cognitive assessment Procedure: psychosocial assessment and care

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	The Vulnerable Elders Survey Study of Older Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Number of impaired domains on Comprehensive Geriatric Assessment (CGA) [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities [ Time Frame: Patients are followed for 1 year for chemotherapy adherence and survival. ] [ Designated as safety issue: No ]
Vulnerable Elders Survey scores [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
Functional decline [ Time Frame: at baseline and 12 months later. ] [ Designated as safety issue: No ]
Time to death [ Time Frame: Patients are followed for 1 year for chemotherapy adherence and survival. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores of individual battery of tools included in the CGA [ Time Frame: at baseline and 12 months later ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Approximately 13mls of blood will be drawn at each of the three time-points for testing for biologic correlates of frailty (pre study, mid-study and post-study).

Enrollment:	63
Study Start Date:	March 2008
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with cancer 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.	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. Other: 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. Other: 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. Procedure: 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.
Patients without cancer non-cancer patients, seeking care at out-patient clinics	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. 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. Other: 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. Other: 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. Procedure: 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.

Groups/Cohorts

Assigned Interventions

Patients with cancer

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.

Behavioral: compliance monitoring