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NCT00963911 · REGISTRY CONDITION SEARCH

Validation of a Screening Tool in Geriatric Oncology

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2021-04-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Sensitivity of the G8 Questionnaire

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outcome · POSTED

Specificity of the G8 Questionnaire

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outcome · POSTED

Sensitivity of the VES-13 Questionnaire

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outcome · POSTED

Specificity of the VES-13 Questionnaire

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outcome · POSTED

Reproducibility of the G8 Questionnaire

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outcome · POSTED

Reproducibility of the VES-13 Questionnaire

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
70 Years
sex
ALL
std Ages
  1. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Screening tests (G8 and VES-13)
    intervention Names
    1. Other: Geriatric screening tests
    2. Other: Multidimensional geriatric assessment
    label
    Included patients
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Included patients
    description
    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.
    name
    Geriatric screening tests
    other Names
    1. G-8
    type
    OTHER
  2. arm Group Labels
    1. Included patients
    description
    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).
    name
    Multidimensional geriatric assessment
    other Names
    1. MGA
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SCREENING
Enrollment
count
1674
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 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. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.
    measure
    Sensitivity of the G8 Questionnaire
    time Frame
    at inclusion (at completion of the G8 questionnaire)
secondary Outcomes
  1. description
    Specificity of the G8 questionnaire measured as percentage of participants with a negative G8 test among patients with a negative MGA.The G8 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. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.
    measure
    Specificity of the G8 Questionnaire
    time Frame
    at inclusion (at completion of the G8 questionnaire)
  2. description
    Sensitivity of the VES-13 questionnaire measured as percentage of participants with a positive VES-13 test among patients with a positive MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 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. Multidimensional geriatric assessment (MGA): see measure description for primary outcome.
    measure
    Sensitivity of the VES-13 Questionnaire
    time Frame
    at inclusion
  3. description
    Specificity of the VES-13 questionnaire measure as the percentage of participants with a negative VES-13 test among patients with a negative MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 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. Multidimensional geriatric assessment (MGA): see measure description for primary outcome.
    measure
    Specificity of the VES-13 Questionnaire
    time Frame
    at inclusion (at completion of the G8 questionnaire)
  4. description
    Reproducibility of G8 was assessed by comparing the score on the actual G8 with the scores extracted from the corresponding seven questions of MNA completed during the MGA for all patients. The G8 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.
    measure
    Reproducibility of the G8 Questionnaire
    time Frame
    at inclusion (at completion of the G8 questionnaire)
  5. description
    Reproducibility of VES-13 was assessed based on a subgroup of patients included in three pre-identified centers who completed the questionnaire on two occasions. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 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.
    measure
    Reproducibility of the VES-13 Questionnaire
    time Frame
    at inclusion (at completion of the G8 questionnaire)
Full study description
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.
Source references
references
  1. 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.
    pmid
    28327973
    type
    BACKGROUND
  2. 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.
    pmid
    25503576
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice