Deployment of Teleconsulting in Geriatric Oncology for Older Patients

NCT ID: NCT05619731

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2027-05-18

Brief Summary

Cancer affects mostly older adults. The development of Geriatric Oncology has greatly improved the management of older patients with the Comprehensive Geriatric Assessments (CGA) being conducted before cancer treatment. A CGA encompasses several dimensions such as comorbidities, but also functional, nutritional or cognitive domains. The International guidelines recommended establishing cooperation with pharmacists as part of the CGA in order to review prescriptions of older patients with cancer and to avoid adverse side effects of treatment. However, the CGA before starting oncological treatment offer is limited in France, especially in some regions which are less populated, or where access to medical centers are difficult. The main objective of our work is to evaluate the impact of telemedicine in geriatric oncology consultation of unexplained re-hospitalization rate at 3 months in the acute care unit. The secondary objectives are to evaluate the impact of telemedicine on unexplained re-hospitalization rate at 6 months, on the secondary toxicities, on the postoperative complications in patients treated surgically, on the overall survival and on the acceptance of the pharmaceutical recommendations by the physicians, but also the impact of telemedicine in medico-economic terms and the satisfaction of patients and oncologists benefiting from teleconsultation.

It is a multicenter, prospective, randomized study involving 500 patients in 9 participating centers, including 6 peripheral hospitals. The experiment will be represented by the implementation of telemedicine in oncology centers where this expertise is not very available, allowing them to benefit from geriatric oncology teleconsultation and pharmaceutical tele-expertise carried out by three university hospitals. Patients recruited by oncologists, according to the inclusion criteria, will give their written consent to participate. Centers were randomized. In the control arm, patients will be treated according to the usual oncological management as defined for each type of cancer. In the interventional arm, patients will benefit from a CGA with a geriatric oncology teleconsultation as well as a pharmaceutical tele-expertise before the initiation of oncological treatment.

Detailed Description

Cancer affects nearly 50% of people over 65 years. The development of Geriatric Oncology has greatly improved the management of older patients with the Comprehensive Geriatric Assessments (CGA) being conducted before cancer treatment. A CGA encompasses several dimensions such as comorbidities, functional, nutritional or cognitive domains. This practice aims to guarantee adapted oncological treatment to their frailties through a multidisciplinary and multi-professional approach. The International guidelines recommended establishing cooperation with pharmacists as part of the CGA in order to review prescriptions of older patients with cancer and avoid adverse side effects of treatment. However, the CGA before starting oncological treatment offer is limited in France, especially in some regions which are less populated, or where access to medical centers are difficult for older patients. Telemedicine is developing in France and is particularly intended for rural populations in order to facilitate access to specialized consultations. The ongoing COVID-19 pandemic episode has clearly enabled to develop telemedicine in hospitals. The main objective of our work is to evaluate the impact of telemedicine in geriatric oncology consultation on the unexplained re-hospitalization rate at 3 months in the acute care unit. The secondary objectives are to evaluate the impact of telemedicine on the unexplained re-hospitalization rate at 6 months, on the secondary toxicities of oncological treatments, on the postoperative complications in patients treated surgically, on the overall survival and on the acceptance of the pharmaceutical recommendations by the physicians, but also on medico-economic terms and on satisfaction of patients and oncologists benefiting from teleconsultation.

It is a multicenter, prospective, randomized study involving 500 patients in 9 participating centers, including 6 peripheral hospitals. The experiment will be represented by the implementation of telemedicine in oncology centers where this expertise is not very available, allowing them to benefit from geriatric oncology teleconsultation and pharmaceutical tele-expertise carried out by three university hospitals. Patients recruited by oncologists, according to the inclusion and non-inclusion criteria, will give their written consent to participate. Centers will be randomized into two arms. In the control arm, patients will be treated according to the usual oncological management as defined for each type of cancer. In the interventional arm, patients will benefit from a CGA with a geriatric oncology teleconsultation as well as a pharmaceutical tele-expertise before the initiation of oncological treatment.

The methodology and analysis plan will be based on the criteria developed by the Consolidated Standards of Reporting Trials Statement (CONSORT) group and more specifically on the extension concerning cluster studies. The expected benefits are a reduction of unexplained re-hospitalizations rate and of inequalities concerning access to care for older patients.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental arm with oncology tele-consultation and pharmaceutical tele-expertise

patients will benefit from geriatric oncology tele-consultation and pharmaceutical tele-expertise

Group Type: EXPERIMENTAL

Geriatric oncology tele-consultation and pharmaceutical tele-expertise

Intervention Type: OTHER

tele consultation

Conventional care

patients will benefit from conventional care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Geriatric oncology tele-consultation and pharmaceutical tele-expertise

tele consultation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients 75 years and older
• Suffering from all types and all stages of cancer and treated for cancer in participating centers
• G8 (screening tool) ≤ 14/17
• Agreeing to benefit from a geriatric oncology assessment
• Having signed a consent
• Affiliated to French social security or a similar French solidarity scheme

Exclusion Criteria

• Patients under guardianship or curatorship or inability to sign consent
• Patients with severe cognitive impairment (MMSE < 10/30)
• Patients with severe hearing or visual impairments as these patients will have difficulty performing the telemedicine consultation
• Patients with a significant language barrier without an interpreter present because these patients will have difficulty carrying out the Telemedicine consultation
• Patients with expectancy less than 3 months

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Laure COUDERC

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hôpitaux de Marseille (AP-HM)

Locations

CH Avignon

Avignon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Clement Pierre

Role: CONTACT

clement.pierre@ap-hm.fr

+33491435796

DRSMR AP-HM

Role: CONTACT

promotion.interne@ap-hm.fr

+33491481499

Facility Contacts

Sylvie KIRSCHER, PhD

Role: primary

Other Identifiers

2021-A02984-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCAPHM21_0428

Identifier Type: -

Identifier Source: org_study_id