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


N/A
65 Years
N/A
Open (Enrolling)
Both
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Determining the Utility of an Assessment Tool for 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

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

Outcome Time Frame:

Prior to chemotherapy and within 30 days of completion of chemotherapy.

Safety Issue:

Yes

Principal Investigator

Arti Hurria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

06170

NCT ID:

NCT00477958

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cognitive/functional effects
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Tower Cancer Research FoundationBeverly Hills, California  90211