Assessing Older Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416481
First received: December 27, 2006
Last updated: November 3, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: cognitive assessment
Procedure: psychosocial assessment and care

Study Type: Observational
Official Title: Development of a Geriatric Assessment Measure for Older Patients With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Mean and median time to complete the entire geriatric assessment
  • Mean number of missing items in each subscale and the distribution of missing items
  • Percentage of patients who identify a scale to be upsetting or difficult to understand
  • 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 completed

Secondary Outcome Measures:
  • Association of continuous sociodemographic/clinical variables with time needed to complete the assessment

Estimated Enrollment: 80
Study Start Date: December 2006
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416481

Locations
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Alice B. Kornblith, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00416481     History of Changes
Other Study ID Numbers: CDR0000523527, CALGB-360401
Study First Received: December 27, 2006
Last Updated: November 3, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 28, 2014