Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma

Phase 4RecruitingNCT07028125

Centre Francois Baclesse83 enrolled

Overview

The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment

Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label. During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma (Kidney Cancer)Metastatic Renal Cell Carcinoma Locally Advanced

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient older than 18 years * Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component * No prior systemic treatment for RCC * Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels * Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used. * Subject affiliated to an appropriate social security system * Patient has signed informed consents obtained before any trial related activities and according to local guidelines Exclusion Criteria: * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study * Patient with history of allergy or hypersensitivity to components of the study drugs * Patient with contraindication to the study drugs * Pregnant or lactating woman * Patient unable to use digital tools * Patient deprived of liberty or placed under the authority of a tutor * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Locations (19)

Centre Hospitalier d'Annecy

Annecy, France

NOT_YET_RECRUITING

Institut Sainte Catherine

Avignon, France

RECRUITING

Centre Hospitalier de Bayeux

Bayeux, France

NOT_YET_RECRUITING

CH Boulogne sur Mer

Boulogne-sur-Mer, France

NOT_YET_RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

Polyclinique du Parc Elsan

Caen, France

NOT_YET_RECRUITING

Institut Andrée Dutreix

Coudekerque-Branche, France

NOT_YET_RECRUITING

Ghpso Creil

Creil, France

NOT_YET_RECRUITING

Institut de cancérologie de Bourgogne

Dijon, France

NOT_YET_RECRUITING

Centre Hospitalier de Lorient

Lorient, France

NOT_YET_RECRUITING

...and 9 more locations

Outcomes

Primary Outcomes

Rate of patients with adjustment of treatments management

rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment

Time frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab)

Secondary Outcomes

- The evolution of self-reported symptoms

report regular follow-up of self-reported symptoms on the digital platform

Time frame: during the first 6 months of the combination (cabozantinb and nivolumab)

- To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment

Follow-up of number of grade 3-4 of self-reported symptoms after modification of treatment management induced by remote follow-up at 3 months

Time frame: during the first 3 months of the combination (cabozantinib and nivolumab)

- To characterize and evaluate regular follow-up of patients self-reported fatigue

Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160)

Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

- To have a longitudinal assessment of general health-related quality of life (QoL)

\- The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40)

Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

- To assess the feasibility of regular follow-up of PROs in real life

The levels of satisfaction and difficulties encountered by patients using the digital monitoring with the French validated version of the self-questionnaire F-SUS System Usability Scale (score between 0 and 50)

Time frame: At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)

- To characterize and describe warning adverse reactions

\- The characterization and description of warning adverse reactions that may require therapeutic adaptation

Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)

- To characterize alerts issued by digital monitoring

Follow-up of number of alerts issued by digital monitoring

Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)

To have a longitudinal assessment of anxiety/depression and pain

The evolution of anxiety/depression with HADS scale (score between 0 and 56)

Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

To characterize alerts issued by digital monitoring

Follow-up on the type of alerts (dose adjustment or treatment discontinuation)

Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma

Overview

Conditions

Interventions

Eligibility

Locations (19)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts