Deployment of Teleconsulting in Geriatric Oncology for Older Patients

Trial Title: Deployment of Teleconsulting in Geriatric Oncology for Older Patients

NCT ID: NCT05619731

Condition: Cancer

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Older adults
Telemedecine
Cancer
Pharmaceutical expertise
Comprehensive Geriatric Assessment
Unexplained re-hospitalization

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Two arms

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Geriatric oncology tele-consultation and pharmaceutical tele-expertise
Description: tele consultation
Arm group label: Experimental arm with oncology tele-consultation and pharmaceutical tele-expertise

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.

Criteria for 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

Gender: All

Minimum age: 75 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CH Avignon

Address:
City: Avignon
Country: France

Status: Recruiting

Contact:
Last name: Sylvie KIRSCHER, PhD

Start date: October 18, 2023

Completion date: May 18, 2027

Lead sponsor:
Agency: Assistance Publique Hopitaux De Marseille
Agency class: Other

Source: Assistance Publique Hopitaux De Marseille

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05619731