Using telemonitoring to manage side effects in cancer patients receiving immunotherapy
Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy
NA · Hospices Civils de Lyon · NCT04605146
This study is testing if a telemonitoring system can help cancer patients receiving immunotherapy for melanoma, lung cancer, or renal cancer manage their side effects better by reporting their symptoms regularly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | nivolumab, ipilimumab, immunotherapy |
| Locations | 10 sites (Bron and 9 other locations) |
| Trial ID | NCT04605146 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a telemonitoring system designed to manage side effects in patients with melanoma, lung cancer, or renal cancer who are being treated with the immunotherapy combination of nivolumab and ipilimumab or adjuvant nivolumab monotherapy. Patients will complete a simplified medical questionnaire weekly, which will provide clinicians with regular feedback on their symptoms. The goal is to reduce the time between the onset of adverse events and their reporting to healthcare providers, thereby improving patient management. This randomized prospective trial aims to assess the efficacy of this remote monitoring approach.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with melanoma, lung cancer, or renal cancer who are starting treatment with nivolumab and ipilimumab.
Not a fit: Patients who are pregnant, under legal protection, or not affiliated with a social security scheme may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and management of severe side effects, improving patient outcomes and quality of life.
How similar studies have performed: Other studies have shown promise in using telemonitoring for managing side effects in cancer treatments, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Patients diagnosed with melanoma, or lung cancer or renal cancer * Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included) * Patients comfortable with the use of digital tools and computing * Patients who agree to participate to the telemonitoring and signed consent form Exclusion Criteria: * Pregnant, parturient and lactating women * Patients under legal protection measure or deprived of their liberty * Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)
Where this trial is running
Bron and 9 other locations
- Groupement hospitalier Est - Multidisciplinary oncological platform — Bron, France (NOT_YET_RECRUITING)
- Hôpital Louis Pradel - Department of Pneumology — Bron, France (NOT_YET_RECRUITING)
- University hospital of Grenoble Alpes - Department of dermatology — Grenoble, France (NOT_YET_RECRUITING)
- University hospital of Grenoble Alpes - Department of Medical Oncology — Grenoble, France (NOT_YET_RECRUITING)
- Hôpital de la Croix Rousse - Department of Pneumology — Lyon, France (NOT_YET_RECRUITING)
- Hôpital Edouard Herriot - Department of urology — Lyon, France (TERMINATED)
- Centre Hospitalier Lyon Sud - Department of Medical Oncology — Pierre-Bénite, France (RECRUITING)
- Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute — Pierre-Bénite, France (RECRUITING)
- Hôpital Lyon Sud - Department of pneumology,Thoracic oncology — Pierre-Bénite, France (RECRUITING)
- University hospital of Saint-Etienne - Department of dermatology — Saint-Etienne, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Stéphane DALLE — Department of Dermatology, HCL-Cancer Institute
- Study coordinator: Stéphane DALLE
- Email: stephane.dalle@chu-lyon.fr
- Phone: 0478861679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma, Lung Cancer, Renal Cancer, Tele-monitoring, nivolumab, ipilimumab, immunotherapy