NCT00477958

Brief Summary

RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer. PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,062

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2006Feb 2027

Study Start

First participant enrolled

December 19, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
19.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

20.2 years

First QC Date

May 23, 2007

Last Update Submit

March 24, 2026

Conditions

Cognitive/Functional EffectsPsychosocial Effects of Cancer and Its TreatmentUnspecified Adult Solid Tumor, Protocol Specific

Keywords

cognitive/functional effectspsychosocial effects of cancer and its treatmentunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool

    Prior to chemotherapy and within 30 days of completion of chemotherapy.

Secondary Outcomes (1)

  • Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters

    Prior to chemotherapy and within 30 days of completion of chemotherapy.

Study Arms (1)

Geriatric Assessment Tool

EXPERIMENTAL
Other: questionnaire administrationProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Interventions

questionnaire administrationOTHER

Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.

Geriatric Assessment Tool
cognitive assessmentPROCEDURE

Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Geriatric Assessment Tool
psychosocial assessment and carePROCEDURE

Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Geriatric Assessment Tool

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Pathologically confirmed cancer * Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen PATIENT CHARACTERISTICS: * Must be able to understand English PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior enrollment in this trial * No concurrent enrollment on a phase I clinical trial

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

Sponsors & Collaborators

Study Sites (8)

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Interventions

Mental Status and Dementia TestsPsychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dale William, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

December 19, 2006

Primary Completion (Estimated)

February 17, 2027

Study Completion (Estimated)

February 17, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(8)