Overview

This trial is active, not recruiting.

Conditions cognitive/functional effects, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
Treatments questionnaire administration, cognitive assessment, psychosocial assessment and care
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date December 2006
End date February 2016
Trial size 750 participants
Trial identifier NCT00477958, 06170, CDR0000540332, CHNMC-06170, MSKCC-06034, P30CA033572

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
questionnaire administration
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
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.

Primary Outcomes

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.

Secondary Outcomes

Measure
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
time frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Determining the Utility of an Assessment Tool for Older Patients With Cancer
Principal investigator Arti Hurria, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.