Clinical trial NCT00963911: Validation of a Screening Tool in Geriatric Oncology
Official title: Validation of a Screening Tool in Geriatric Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Head and Neck Cancer
Lung Cancer
Lymphoma
Prostate Cancer
Keywords: 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
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2009-08-24
Enrollment: 1674
Sex: ALL
Minimum age (years): 70
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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 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

Primary outcomes:
measure: Sensitivity of the G8 Questionnaire
timeFrame: at inclusion (at completion of the G8 questionnaire)
Secondary outcomes:
measure: Specificity of the G8 Questionnaire
timeFrame: at inclusion (at completion of the G8 questionnaire)
measure: Sensitivity of the VES-13 Questionnaire
timeFrame: at inclusion
measure: Specificity of the VES-13 Questionnaire
timeFrame: at inclusion (at completion of the G8 questionnaire)
measure: Reproducibility of the G8 Questionnaire
timeFrame: at inclusion (at completion of the G8 questionnaire)
measure: Reproducibility of the VES-13 Questionnaire
timeFrame: at inclusion (at completion of the G8 questionnaire)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
affiliation: Institut Bergonié
name: Pierre Soubeyran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pelissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068.
citation: Soubeyran P, Bellera C, Goyard J, Heitz D, Cure H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Perin S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pelissier S, Rainfray M. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study. PLoS One. 2014 Dec 11;9(12):e115060. doi: 10.1371/journal.pone.0115060. eCollection 2014.