Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

Centre Paul Strauss

Status: Enrolling

Conditions: Neoplasms; Digestive System Disease

Treatments: Other: EPODIG-G program (coordination of supportive care)

Study type: Interventional

Funder types: Other

Identifiers

NCT05066139

2020-018

2021-A00956-35 (Other Identifier)

Details and patient eligibility

About

This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

Full description

At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.

Enrollment: 144 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be ≥ 75 years old
• Performance status 0, 1 or 2
• Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy for a treatment period of 24 weeks or more
• Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
• Estimated life expectancy ≥ 3 months
• Patients able to speak, read and understand French
• Signed informed consent from the patient
• Patients must have a social security coverage

Exclusion criteria

• History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
• Cancer currently being treated (except for hormone therapy) other than current digestive cancer
• History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
• Patients unable to submit to medical follow-up for geographical, social or psychological reasons
• Patients placed under guardianship

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Arm A Standard of care

No Intervention group

Description:

Patients will receive standard care before treatment initiation (i.e. geriatric assessment only). Geriatric assessment includes: Mini Mental State Examination ; mini-Geriatric Depression Scale (mini-GDS) ; Body Mass Index (BMI) calculation ; Mini Nutritional Assessment (MNA) ; Time up and Go ; Cumulative Illness Rating Scale - Geriatric (CIRS-G) ; Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) questionnaires.

Arm B Multidisciplinary EPODIG program

Experimental group

Description:

Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.

Treatment:

Other: EPODIG-G program (coordination of supportive care)