NCT00477958

Assessment Tool for Older Patients With Cancer

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,062 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-12-19
• Primary completion: 2027-02-17
• Completion: 2027-02-17
• First posted: 2007-05-24
• Last updated: 2026-03-27

Locations

8 sites across 1 country: United States