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Assessing Older Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00416481
First received: December 27, 2006
Last updated: July 12, 2016
Last verified: July 2016

December 27, 2006
July 12, 2016
December 2006
October 2011   (final data collection date for primary outcome measure)
  • Mean and median time to complete the entire geriatric assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Mean number of missing items in each subscale and the distribution of missing items [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Percentage of patients who identify a scale to be upsetting or difficult to understand [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00416481 on ClinicalTrials.gov Archive Site
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Assessing Older Patients With Cancer
Development of a Geriatric Assessment Measure for Older Patients With Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients aged 65 years and older with a histologically confirmed malignancy enrolled on any cooperative group-sponsored cancer treatment trial.
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: quality of life questionnaires
Patient assessment

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.

Intervention: Behavioral: quality of life questionnaires
Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, Schmieder L, Ansari R, Tew WP, Weckstein D, Kirshner J, Togawa K, Hansen K, Katheria V, Stone R, Galinsky I, Postiglione J, Cohen HJ. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00416481
CALGB-360401, CALGB-360401, CDR0000523527
No
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Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Alice B. Kornblith, PhD Dana-Farber Cancer Institute
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP