Deployment of Teleconsulting in Geriatric Oncology for Older Patients

NCT05619731 | Recruiting

• 2 other identifiers: RCAPHM21_04282021-A02984-37
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Older adults; Telemedecine; Cancer; Pharmaceutical expertise; Comprehensive Geriatric Assessment; Unexplained re-hospitalization

Outcome Measures

Primary Outcomes (1)

• 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).

  Unexplained re-hospitalization rate at 3 months

  Three months after inclusion

Study Arms (2)

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

EXPERIMENTAL

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

Other: Geriatric oncology tele-consultation and pharmaceutical tele-expertise

Conventional care

NO INTERVENTION

patients will benefit from conventional care

Interventions

Geriatric oncology tele-consultation and pharmaceutical tele-expertise OTHER

tele consultation

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

CH Avignon

Avignon, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Anne-Laure COUDERC

  Assistance Publique des Hôpitaux de Marseille (AP-HM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clement Pierre

CONTACT

+33491435796; clement.pierre@ap-hm.fr

DRSMR AP-HM

CONTACT

+33491481499; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: October 18, 2023
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): May 18, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)