Questionnaire in Screening Older Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963911
First received: August 21, 2009
Last updated: May 12, 2011
Last verified: May 2011

August 21, 2009
May 12, 2011
June 2008
May 2011   (final data collection date for primary outcome measure)
Validation of G8 screening tool [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963911 on ClinicalTrials.gov Archive Site
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Questionnaire in Screening Older Patients With Cancer
Validation of a Screening Tool in Geriatric Oncology

RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

OBJECTIVES:

Primary

  • Validate a new screening tool (G8).

Secondary

  • Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
  • Evaluate the merits of the screening tools (G8 and VES-13).
  • Assess the screening tool in specific populations.
  • Assess the number and type of interventions proposed after thorough geriatric assessment.
  • Compare the two new tools (G8 vs VES-13).

OUTLINE: This is a multicenter study.

During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected.

Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.

Interventional
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Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Screening
  • Breast Cancer
  • Colorectal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Lymphoma
  • Prostate Cancer
  • Other: medical chart review
  • Other: screening questionnaire administration
  • Procedure: comparison of screening methods
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1650
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May 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer including the following types:

    • Colon
    • Rectal
    • Lung
    • Squamous cell carcinoma of the head and neck
    • Breast
    • Prostate
    • Non-Hodgkin lymphoma
  • Planning to undergo first-time treatment comprising medicine, surgery, or radiotherapy

PATIENT CHARACTERISTICS:

  • No persons deprived of liberty or under guardianship
  • No psychological, familial, social, or geographical reasons that would make monitoring clinically impossible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00963911
CDR0000637122, IB-ONCODAGE, IB 2008-06, RECF0891
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Institut Bergonié
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Principal Investigator: Pierre Soubeyran, MD, PhD Institut Bergonié
National Cancer Institute (NCI)
May 2011

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