Clinical trial NCT05619731: Deployment of Teleconsulting in Geriatric Oncology for Older Patients
Official title: Deployment of Teleconsulting in Geriatric Oncology for Patients Aged 75years or Older Initiating an Oncologic Treatment and Living in Remote Area With no or Few Access to Geriatric Oncology Evaluation Nearby Their Oncologic Treatment Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Older adults
Telemedecine
Cancer
Pharmaceutical expertise
Comprehensive Geriatric Assessment
Unexplained re-hospitalization
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Evaluation of the impact of telemedicine in geriatric oncology on the unexplained re-hospitalization rate at 3 months in the medicine-surgery-oncology-acute care units (with or without going through the emergency department).
timeFrame: Three months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: CH Avignon
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille (AP-HM)
name: Anne-Laure COUDERC
role: PRINCIPAL_INVESTIGATOR
References: