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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2030-10-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Digestive System Disease Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A Standard of care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm B Multidisciplinary EPODIG program

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

Group Type EXPERIMENTAL

EPODIG-G program (coordination of supportive care)

Intervention Type OTHER

EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)

Interventions

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EPODIG-G program (coordination of supportive care)

EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No