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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach

1 country

5 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

March 1, 2008

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

August 22, 2008

Last Update Submit

July 23, 2020

Conditions

Breast Cancer Cognitive/Functional Effects Colorectal Cancer Psychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentcognitive/functional effectsbreast cancercolon cancer

Outcome Measures

Primary Outcomes (5)

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 Outcomes (1)

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

Study Arms (2)

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 monitoringDrug: systemic chemotherapyOther: medical chart reviewOther: study of socioeconomic and demographic variablesOther: survey administrationProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Patients without cancer

non-cancer patients, seeking care at out-patient clinics

Behavioral: compliance monitoringOther: medical chart reviewOther: study of socioeconomic and demographic variablesOther: survey administrationProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Interventions

compliance monitoringBEHAVIORAL

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.