Assessing Older Patients With Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Behavioral: quality of life questionnaires

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00416481

CDR0000523527 (Registry Identifier)

CALGB-360401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

93 participants in 1 patient group

Patient assessment

Description:

Patients undergo assessments of cognition 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 self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support. Patients then begin planned treatment.

Treatment:

Behavioral: quality of life questionnaires