Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

Terminated

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

• Registration Number: NCT00740961
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cancer	systemic chemotherapy	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.
Patients with cancer	study of socioeconomic and demographic variables	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.
Patients without cancer	medical chart review	non-cancer patients, seeking care at out-patient clinics
Patients without cancer	cognitive assessment	non-cancer patients, seeking care at out-patient clinics
Patients without cancer	compliance monitoring	non-cancer patients, seeking care at out-patient clinics
Patients without cancer	psychosocial assessment and care	non-cancer patients, seeking care at out-patient clinics
Patients with cancer	compliance monitoring	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.
Patients with cancer	medical chart review	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.
Patients with cancer	survey administration	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.
Patients without cancer	survey administration	non-cancer patients, seeking care at out-patient clinics
Patients with cancer	psychosocial assessment and care	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.
Patients without cancer	study of socioeconomic and demographic variables	non-cancer patients, seeking care at out-patient clinics
Patients with cancer	cognitive assessment	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.

Primary Outcome Measures

Name	Time	Method
Number of impaired domains on Comprehensive Geriatric Assessment (CGA)	at baseline and 12 months later.
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.
Vulnerable Elders Survey scores	at baseline and 12 months later.
Functional decline	at baseline and 12 months later.
Time to death	Patients are followed for 1 year for chemotherapy adherence and survival.

Secondary Outcome Measures

Name	Time	Method
Scores of individual battery of tools included in the CGA	at baseline and 12 months later

Trial Locations

Locations (5)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UH-Westlake; 🇺🇸 Westlake, 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