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Assessing Older Patients With Cancer

Development of a Geriatric Assessment Measure for Older Patients With Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00416481
Enrollment
93
Registered
2006-12-28
Start date
2006-12-31
Completion date
2011-10-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer. PURPOSE: This clinical trial is studying ways to assess older patients with cancer.

Detailed description

OBJECTIVES: Primary * Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer. * Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance. * Determine the length of time necessary to complete the geriatric assessment. * Determine the variance and number of missing items. * Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend. * Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status. Secondary * Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status. OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over). Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. 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 treatment.

Interventions

BEHAVIORALquality of life questionnaires

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed malignancy at any stage * Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit PATIENT CHARACTERISTICS: * Any performance status allowed * Must be able to follow directions in English * Sufficient cognitive and psychological function to give consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Mean and median time to complete the entire geriatric assessmentUp to 3 years
Mean number of missing items in each subscale and the distribution of missing itemsUp to 3 years
Percentage of patients who identify a scale to be upsetting or difficult to understandUp to 3 years
Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completedUp to 3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026