Validation of a Screening Tool in Geriatric Oncology
Condition: Breast Cancer; Colorectal Cancer; Head and Neck Cancer; Lung Cancer; Lymphoma; Prostate Cancer
MeSH terms: Lung Neoplasms; Prostatic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Geriatric screening tests; Multidimensional geriatric assessment
Intervention type(s): Other; Other
Intervention description(s): The G-8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14 and the time taken to complete the test was recorded.
VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.; Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study).
Other intervention name(s): G-8; MGA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
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