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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 (MONITOR)

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ClinicalTrials.gov Identifier: NCT04605146
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE October 16, 2020
First Posted Date  ICMJE October 27, 2020
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE May 5, 2021
Estimated Primary Completion Date May 1, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
Delay between the start of a side effect and reporting to the medical team (average number of days per patient). [ Time Frame: 12 months ]
The delay between the start of a side effect and medical information will be calculated for each AE and average per patient in each of the two groups studied, with its 95% confidence interval.The delays of the two groups will be compared using a Mann-Whitney test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Levels of morbidity based on CTC-AE v5 (all toxicities) [ Time Frame: 12 months ]
    Levels of morbidity based on CTC-AE v5 (all toxicities) will be compare using a generalised log linear regression. In case of several AEs, the average medical information per patient will be considered.
  • Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction [ Time Frame: 12 months ]
    Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction will be compared in the two groups using a Mann-Whitney test
  • Number of admissions in the emergency room [ Time Frame: 12 months ]
    Number of admissions in the emergency room will be compared in the two groups with a Wilcoxon rank sum test. The rate of admissions per patient-years will be calculated and compared between the 2 groups with a Negative Binomial generalized linear regression model accounting for overdispersed data and correlated events, using the log of follow-up time as an offset.
  • Number of unplanned hospitalizations [ Time Frame: 12 months ]
    Number of unplanned hospitalizations will be compared in the two groups with a Wilcoxon rank sum test. The hospitalizations per patient-years will be calculated and compared between the 2 groups with a Negative Binomial generalized linear regression model accounting for overdispersed data and correlated events, using the log of follow-up time as an offset.
  • Number of contact with general practitioner [ Time Frame: 12 months ]
    Number of contact with general practitioner will be compared in the two groups with a Wilcoxon rank sum test.
  • benefit for clinicians: interview of clinicians on their opinion on the self-monitoring, evaluation to the impact on the consultations during the first year of treatment, assessed with satisfaction questionnaires [ Time Frame: Month 12 ]
    benefit for clinicians will be compared in the 2 groups with adequate test according to the retained satisfaction scale
  • Number of AE identified by clinicians [ Time Frame: 12 months ]
    Number of AE identified by clinicians will be compared in the two groups with a Wilcoxon rank sum test. In addition, the competitive risk of death with the recurrent events process will be explored using a joint frailty model (Rondeau V. et al. Joint frailty models for recurring events and death using maximum penalized likelihood estimation: application on cancer events. Biostatistics (2007), 8, 4, pp. 708-721).
  • Overall quality of Life assessed with standardized QoL questionnaires (FACT-G) [ Time Frame: 12 months ]
    Overall quality of Life will be described and compared between the two groups with the Student t-test, or the Wilcoxon rank-sum test in case of non-normality of the distributions. All data recorded at the follow-up visits will be considered, whatever the actual date of the visit
  • Adherence: The number of full symptoms report completions and adherence to the completion schedule [ Time Frame: 12 months ]
    Adherence will be described in the experimental group. All data recorded at the follow-up visits will be considered, whatever the actual date of the visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2020)
  • Overall Survival and Progression Free Survival assessed at 1 year after inclusion [ Time Frame: At 1 year after inclusion ]
    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach
  • Overall Survival and Progression Free Survival assessed at 2 years after inclusion [ Time Frame: At 2 years after inclusion ]
    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach
  • Overall Survival and Progression Free Survival assessed at 5 years after inclusion [ Time Frame: At 5 years after inclusion ]
    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief Summary

The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.

The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Melanoma
  • Lung Cancer
  • Renal Cancer
Intervention  ICMJE Behavioral: Tele-monitoring

The tele-monitoring will consist in filling in a specific questionnaire once a week in the first 6 months, every 2 weeks until 12 months, and on-demand (in case of upcoming toxicity, at any time). These questionnaires will be reviewed by a coordinating nurse. According to the result of the questionnaire, the coordinating nurse will adapt patients' management, either by giving them a phone call, or inviting them to directly contact their medical department, or even plan an emergency hospitalization if necessary. The coordinating nurse will closely work with the investigator to adapt patients' management.

Quality of life questionnaire (FACT-G) will also be filled in at inclusion, M3 and M12.

Study Arms  ICMJE
  • Experimental: Tele-monitoring group

    In the experimental group, in addition to routine practice, each patient will benefit of a tele-monitoring of one year, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.

    50 patients are expected in this arm.

    Intervention: Behavioral: Tele-monitoring
  • No Intervention: Control group

    In the control group, patients will have a routine follow-up as per institutional practice, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.

    50 patients are expected in this arm.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2028
Estimated Primary Completion Date May 1, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stéphane DALLE 0478861679 ext +33 stephane.dalle@chu-lyon.fr
Contact: Aurélie RABIER 0478861679 ext +33 aurelie.rabier@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04605146
Other Study ID Numbers  ICMJE 69HCL20_0492
2020-A02372-37 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stéphane DALLE Department of Dermatology, HCL-Cancer Institute
PRS Account Hospices Civils de Lyon
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP