Assessment Tool for Older Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00477958
First received: May 23, 2007
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Cognitive/Functional Effects
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Determining the Utility of an Assessment Tool for Older Patients With Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters [ Time Frame: Prior to chemotherapy and within 30 days of completion of chemotherapy. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2007
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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 500 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477958

Locations
United States, California
Tower Cancer Research Foundation Recruiting
Beverly Hills, California, United States, 90211
Contact: Robert W. Decker, MD    310-888-8680      
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen    800-826-4673    becomingapatient@coh.org   
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent    877-827-8839    ucstudy@uci.edu   
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center    203-785-5702      
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: William P. Tew, MD    212-639-6555    teww@mskcc.org   
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Supriya Mohile, MD    585-275-5513      
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Arti Hurria, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00477958     History of Changes
Other Study ID Numbers: 06170, P30CA033572, CHNMC-06170, MSKCC-06034, CDR0000540332
Study First Received: May 23, 2007
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
cognitive/functional effects
psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 22, 2014