Assessment Tool for Older Patients With Cancer

Not Applicable

Active, not recruiting

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

• Registration Number: NCT00477958
• Lead Sponsor: City of Hope Medical Center

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 Timeline

• Study Start: 2006-12-19
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2015-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Study Completion: 2026-03-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1062

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Geriatric Assessment Tool	cognitive assessment	-
Geriatric Assessment Tool	psychosocial assessment and care	-
Geriatric Assessment Tool	questionnaire administration	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters	Prior to chemotherapy and within 30 days of completion of chemotherapy.

Trial Locations

Locations (8)

Tower Cancer Research Foundation; 🇺🇸 Beverly Hills, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, 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

James P. Wilmot Cancer Center at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States