Summary

Eligibility
for people ages 65-120 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Determining the Utility of an Assessment Tool for Older Patients With Cancer

Details

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.

Keywords

Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific, cognitive assessment, psychosocial assessment and care, Geriatric Assessment Tool

Eligibility

For people ages 65-120

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

Locations

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    Orange California 92868 United States
  • City of Hope Medical Center
    Duarte California 91010-3000 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
City of Hope Medical Center
ID
NCT00477958
Study Type
Interventional
Participants
About 1062 people participating
Last Updated