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Active, not recruitingNCT00477958Updated Mar 27, 2026

Assessment Tool for Older Patients With Cancer

An interventional study of questionnaire administration and cognitive assessment in Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center. Active, not recruiting at 8 sites in United States. Open to participants aged 65 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2006, registered May 2007).
Phase
Not applicable
Study type
Interventional
Enrollment
1,062
Allocation
Not applicable
Ages
65 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.

Secondary

  • Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.

OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.

Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).

Patients then begin planned chemotherapy.

After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.

02

Conditions studied

  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • cognitive/functional effects
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,062 participants (actual)

Study arms

  • Experimental
    Geriatric Assessment Tool

    Other: questionnaire administration · Procedure: cognitive assessment · Procedure: psychosocial assessment and care

Interventions

  • Otherquestionnaire administration

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

  • Procedurecognitive assessment

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

  • Procedurepsychosocial assessment and care

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

06

What researchers measure

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

    Time frame: 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

    Time frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.

07

Study locations

8 sites
  • Tower Cancer Research Foundation
    Beverly Hills, California 90211, United States
  • City of Hope Medical Center
    Duarte, California 91010-3000, United States
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    Orange, California 92868, United States
  • Yale Cancer Center
    New Haven, Connecticut 06520-8028, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00477958
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 24, 2007
Start date
Dec 19, 2006
Primary completion
Feb 17, 2027 (estimated)
Completion
Feb 17, 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Dale William, MD
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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