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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Screening
Official Title: Validation of a Screening Tool in Geriatric Oncology

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Validation of G8 screening tool [ Designated as safety issue: No ]

Estimated Enrollment: 1650
Study Start Date: June 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00963911

Locations
France
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Pierre Soubeyran, MD, PhD Institut Bergonié
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00963911     History of Changes
Other Study ID Numbers: CDR0000637122, IB-ONCODAGE, IB 2008-06, RECF0891
Study First Received: August 21, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
non-small cell lung cancer
small cell lung cancer
hypopharyngeal squamous cell carcinoma
laryngeal squamous cell carcinoma
laryngeal verrucous carcinoma
lip and oral cavity squamous cell carcinoma
oral cavity verrucous carcinoma
nasopharyngeal squamous cell carcinoma
oropharyngeal squamous cell carcinoma
paranasal sinus and nasal cavity squamous cell carcinoma
salivary gland squamous cell carcinoma
prostate cancer
breast cancer
adult non-Hodgkin lymphoma

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Lymphoma
Prostatic Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Immune System Diseases
Immunoproliferative Disorders
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Prostatic Diseases
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014