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Validation of a Screening Tool in Geriatric Oncology (ONCODAGE)

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ClinicalTrials.gov Identifier: NCT00963911
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : January 26, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Institut Bergonié

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Lymphoma Prostate Cancer Other: Geriatric screening tests Other: Multidimensional geriatric assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1674 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validation of a Screening Tool in Geriatric Oncology
Actual Study Start Date : August 5, 2008
Actual Primary Completion Date : March 8, 2010
Actual Study Completion Date : March 8, 2015


Arm Intervention/treatment
Experimental: Included patients
Screening tests (G8 and VES-13)
Other: Geriatric screening tests

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.

Other Name: G-8

Other: Multidimensional geriatric assessment
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 Name: MGA




Primary Outcome Measures :
  1. Sensitivity of the G8 Questionnaire [ Time Frame: at inclusion (at completion of the G8 questionnaire) ]

    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.



Secondary Outcome Measures :
  1. Specificity of the G8 Questionnaire [ Time Frame: at inclusion (at completion of the G8 questionnaire) ]

    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.


  2. Sensitivity of the VES-13 Questionnaire [ Time Frame: at inclusion ]

    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.


  3. Specificity of the VES-13 Questionnaire [ Time Frame: at inclusion (at completion of the G8 questionnaire) ]

    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.


  4. Reproducibility of the G8 Questionnaire [ Time Frame: at inclusion (at completion of the G8 questionnaire) ]
    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.

  5. Reproducibility of the VES-13 Questionnaire [ Time Frame: at inclusion (at completion of the G8 questionnaire) ]
    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.



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Ages Eligible for Study:   70 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963911


Locations
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France
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
National Cancer Institute, France
Investigators
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Principal Investigator: Pierre Soubeyran, MD, PhD Institut Bergonié
Publications of Results:
Other Publications:
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT00963911    
Other Study ID Numbers: IB 2008-06
IB-ONCODAGE ( Other Identifier: Insitut Bergonie )
IB 2008-06 ( Other Identifier: Insitut Bergonie )
2008-A00322-53 ( Other Identifier: AFSSAPS )
First Posted: August 24, 2009    Key Record Dates
Results First Posted: January 26, 2021
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
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:
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Lung Neoplasms
Prostatic Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases