NCT00873600

Brief Summary

RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients. PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

First QC Date

March 31, 2009

Last Update Submit

March 17, 2015

Conditions

Breast CancerCognitive/Functional EffectsColorectal CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

cognitive/functional effectspsychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast canceradenocarcinoma of the colonstage I colon cancerstage II colon cancerstage III colon cancer

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities

Secondary Outcomes (3)

  • Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization

  • Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization

  • 3-year disease-free survival

Interventions

chemotherapyDRUG
medical chart reviewOTHER
questionnaire administrationOTHER
adjuvant therapyPROCEDURE
assessment of therapy complicationsPROCEDURE
cognitive assessmentPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma, including one of the following: * Breast cancer (female), meeting the following criteria: * Stage I-III (T1-4, N0-3, M0) disease * Has undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy * Has undergone either sentinel lymph node dissection or axillary lymph node dissection with adequate TNM staging * Colon cancer (male or female), meeting the following criteria: * Stage I-III (T1-3, any N, M0) disease * Has undergone appropriate surgical resection with TNM staging * Newly diagnosed disease * Scheduled to receive chemotherapy * Agrees to receive chemotherapy AND is able to receive chemotherapy within 3 months after surgery * No distant metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 6 months * Fluent in English * Not living in a nursing home * No end-stage disease * No severe dementia * No other clinically active malignancy within the past 5 years or within 3 months after diagnosis of current malignancy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for the malignancy * More than 1 year since prior treatment on an inpatient/outpatient geriatric evaluation and management unit

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsColonic Neoplasms

Interventions

Drug TherapyChemotherapy, AdjuvantMental Status and Dementia TestsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapyNeuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Cynthia Owusu, MD, MSC

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

October 1, 2007

Last Updated

March 19, 2015

Record last verified: 2015-03