Assessment Tool for Older Patients With Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00477958
• Other study ID #: 06170
• Secondary ID: P30CA033572CHNMC
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2006
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1062
• Est. completion date: December 31, 2024
• Est. primary completion date: July 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive/Functional Effects
• Psychosocial Effects of Cancer and Its Treatment
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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.
• psychosocial assessment and care
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Locations

Country	Name	City	State
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	City of Hope Medical Center	Duarte	California
United States	Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Prior to chemotherapy and within 30 days of completion of chemotherapy.
Secondary	Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters		Prior to chemotherapy and within 30 days of completion of chemotherapy.