Text Size

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
History of Changes

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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1650
Not Provided
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
Not Provided
Not Provided
Institut Bergonié
Not Provided
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