Assessment Tool for Older Patients With Cancer

March 18, 2024 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1062

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric Assessment Tool
Other: questionnaire administration
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
Procedure: cognitive assessment
Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
Procedure: psychosocial assessment and care
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Prior to chemotherapy and within 30 days of completion of chemotherapy.

Secondary Outcome Measures

Outcome Measure
Time Frame
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
Time Frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.
Prior to chemotherapy and within 30 days of completion of chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dale William, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2006

Primary Completion (Actual)

July 27, 2015

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimated)

May 24, 2007

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06170
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-06170
  • MSKCC-06034
  • CDR0000540332 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trials on questionnaire administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe