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Active, Not Recruiting

NCT Number: NCT00477958

Assessment Tool for Older Patients With Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tower Cancer Research Foundation, Beverly Hills, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.

cognitive assessment

Procedure

Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

psychosocial assessment and care

Procedure

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

Primary outcomes

  1. 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

  1. Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters

    Time frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2027
Study completion
2027
First posted
May 24, 2007
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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