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Assessment Tool for Older Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00477958
Recruitment Status : Active, not recruiting
First Posted : May 24, 2007
Last Update Posted : March 18, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE May 23, 2007
First Posted Date  ICMJE May 24, 2007
Last Update Posted Date March 18, 2022
Actual Study Start Date  ICMJE December 19, 2006
Actual Primary Completion Date July 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2007)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters [ Time Frame: Prior to chemotherapy and within 30 days of completion of chemotherapy. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2007)
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment Tool for Older Patients With Cancer
Official Title  ICMJE Determining the Utility of an Assessment Tool for Older Patients With Cancer
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Geriatric Assessment Tool
Interventions:
  • Other: questionnaire administration
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2014)
750
Original Enrollment  ICMJE
 (submitted: May 23, 2007)
500
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date July 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 120 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00477958
Other Study ID Numbers  ICMJE 06170
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-06170
MSKCC-06034
CDR0000540332 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party City of Hope Medical Center
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE City of Hope Medical Center
Original Study Sponsor  ICMJE Beckman Research Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Arti Hurria, MD City of Hope Comprehensive Cancer Center
PRS Account City of Hope Medical Center
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP