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

May 23, 2007
April 9, 2014
January 2007
October 2015   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00477958 on ClinicalTrials.gov Archive Site
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 ]
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
Not Provided
Not Provided
 
Assessment Tool for Older Patients With Cancer
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
October 2015   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
United States
 
NCT00477958
06170, P30CA033572, CHNMC-06170, MSKCC-06034, CDR0000540332
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Arti Hurria, MD Beckman Research Institute
City of Hope Medical Center
April 2014

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