Validation of a Screening Tool in Geriatric Oncology (ONCODAGE)

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Breast Cancer; Head and Neck Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer
• Intervention / Treatment: Other: Geriatric screening tests; Other: Multidimensional geriatric assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 1674
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 120 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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 Names: MGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at inclusion (at completion of the G8 questionnaire)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion (at completion of the G8 questionnaire)

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: Pierre Soubeyran, MD, PhD, Institut Bergonié

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2008
• Primary Completion (Actual): March 8, 2010
• Study Completion (Actual): March 8, 2015

Study Registration Dates

• First Submitted: August 21, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 24, 2009

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; prostate cancer; non-small cell lung cancer; rectal cancer; colon cancer; small cell lung cancer; lip and oral cavity squamous cell carcinoma; oropharyngeal squamous cell carcinoma; salivary gland squamous cell carcinoma; hypopharyngeal squamous cell carcinoma; laryngeal squamous cell carcinoma; nasopharyngeal squamous cell carcinoma; paranasal sinus and nasal cavity squamous cell carcinoma; adult non-Hodgkin lymphoma; laryngeal verrucous carcinoma; oral cavity verrucous carcinoma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Prostatic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IB 2008-06 (Other Identifier: Insitut Bergonie); IB-ONCODAGE (Other Identifier: Insitut Bergonie); 2008-A00322-53 (Other Identifier: AFSSAPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No