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Validation of a Screening Tool in Geriatric Oncology (ONCODAGE)

Primary Purpose

Breast Cancer, Colorectal Cancer, Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Geriatric screening tests
Multidimensional geriatric assessment
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring 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

Eligibility Criteria

70 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Included patients

Arm Description

Screening tests (G8 and VES-13)

Outcomes

Primary Outcome Measures

Sensitivity 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

Specificity 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.
Sensitivity of the VES-13 Questionnaire
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.
Specificity of the VES-13 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.
Reproducibility 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.
Reproducibility of the VES-13 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.

Full Information

First Posted
August 21, 2009
Last Updated
March 9, 2021
Sponsor
Institut Bergonié
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT00963911
Brief Title
Validation of a Screening Tool in Geriatric Oncology
Acronym
ONCODAGE
Official Title
Validation of a Screening Tool in Geriatric Oncology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2008 (Actual)
Primary Completion Date
March 8, 2010 (Actual)
Study Completion Date
March 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1674 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Included patients
Arm Type
Experimental
Arm Description
Screening tests (G8 and VES-13)
Intervention Type
Other
Intervention Name(s)
Geriatric screening tests
Other Intervention Name(s)
G-8
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Multidimensional geriatric assessment
Other Intervention Name(s)
MGA
Intervention 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).
Primary Outcome Measure Information:
Title
Sensitivity of the G8 Questionnaire
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.
Time Frame
at inclusion (at completion of the G8 questionnaire)
Secondary Outcome Measure Information:
Title
Specificity of the G8 Questionnaire
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.
Time Frame
at inclusion (at completion of the G8 questionnaire)
Title
Sensitivity of the VES-13 Questionnaire
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.
Time Frame
at inclusion
Title
Specificity of the VES-13 Questionnaire
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.
Time Frame
at inclusion (at completion of the G8 questionnaire)
Title
Reproducibility of the G8 Questionnaire
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.
Time Frame
at inclusion (at completion of the G8 questionnaire)
Title
Reproducibility of the VES-13 Questionnaire
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.
Time Frame
at inclusion (at completion of the G8 questionnaire)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Soubeyran, MD, PhD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28327973
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.
Results Reference
background
PubMed Identifier
25503576
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.
Results Reference
result

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Validation of a Screening Tool in Geriatric Oncology

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