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A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients (TavieSkin)

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ClinicalTrials.gov Identifier: NCT04911998
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief Summary:
  1. Background The purpose of this study is to describe the profile of patients with BRAF-mutated melanoma treated with BRAF/MEK inhibitors combination and using the Tavie Skin application.

    TavieSkin app, a digital solution developped by Pierre Fabre, is dedicated to all BRAF-mutant unresectable or metastatic melanoma patients who are treated with "any" targeted therapies.

  2. Study objectives The primary objective of the survey is to describe the demographics and clinical characteristics of patients with unresectable or metastatic BRAF-mutated melanoma treated with targeted therapy (BRAFi/MEKi) and using the TavieSkin application

    The secondary objectives include:

    • To assess the use of TavieSkin app in patients with unresectable or metastatic BRAF-mutated melanoma treated with BRAFi/MEKi combination;
    • To assess the treatment adherence of patients using TavieSkin app including treatment interruption or permanent discontinuation;
    • To assess the health-related quality of life of patients using TavieSkin app (FACT-M);
    • To assess work productivity and activity impairment over the treatment duration
    • To assess the patient satisfaction toward the TavieSkin application;
    • To assess the patient satisfaction toward the treatment.
  3. Research methods

3.1 Study design This prospective, longitudinal, survey will be conducted in Europe to characterize BRAF-mutant unresectable or metastatic melanoma patients using TavieSkin app designed for accompanying patients treated with targeted therapies.

To date, there are three combinations of BRAFi/MEKi available in routine practice for the treatment of BRAF-mutant unresectable or metastatic melanoma. The survey does not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physicians in accordance with their usual practices. The patients initiating any BRAFi/MEKi combination will be invited to use the TavieSkin app by their healthcare provider (HCP) (i.e. oncologist, dermatologist, nurse…).

Once the patient has installed and started to use the application, an e-survey will be proposed to the patient via the app. A detailed information letter about the data collection, data privacy and analysis will be displayed to the patient via the app along with an e-consent for data collection. The patient will be able then to provide an e-signature, if he/she accepts to take part of this survey. The survey will collect anonymized data about health status, QoL data and satisfaction. These data will be collected by the patient only. The physician will not be involved in this e-survey (including e-consent), nor in data collection.

Only patients having given consent (e-consent) to data collection and analysis will be included. Data will be collected at baseline and at different subsequent timepoints during the BRAFi/MEKi treatment duration only. Only data reported by the patients in the application will be collected and analyzed.

The patient will discontinue the study in case of definitive withdrawal of BRAFi/MEKi treatment, or if he/she decides to withdraw the study and to stop data collection.

The target countries for patient enrollment will include Germany, Belgium, Portugal, France, Spain, Italy and Sweden with the additional possibility of including patients from other EU countries.

At least, 400 adult patients (≥18 years) will be enrolled.

3.2 Population (see section: Eligibility)

3.3 Study outcomes (see section: Outcome measures)

3.4 Statistical considerations Statistical analyses will be fully described in a written statistical analysis plan (SAP). The study endpoints will be analysed overall and by country. Analyses will be descriptive in nature, as no hypothesis will be tested.

The treatment patterns of patients, baseline demographics and clinical characteristics, and reasons for treatment discontinuation will be described using summary statistics. Categorical variables will be summarized by frequencies and percentages. Continuous variables will be summarized by descriptive statistics (mean, and standard deviation, median, 25th and 75th percentiles, minimum and maximum). The number of missing observations for each variable will also be reported.

Change in health-related quality-of-life scores (i.e. (FACT-M) will be summarised at baseline and at each timepoints. The change from baseline will be assessed using a mixed model for repeated measures (MMRM).

Time to event data (i.e. time to treatment discontinuation, time QoL deterioration) will be evaluated using Kaplan-Meier survival curves. Median survival estimates will be reported along with the 25th and 75th percentiles and corresponding 95% confidence intervals (CIs). Cox regression analysis may be performed to adjust for predefined (baseline) covariates.

If the sample size is adequate, subgroup analyses using variables at baseline might be conducted.


Condition or disease
Melanoma (Skin) Metastatic Melanoma BRAF V600 Mutation

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Non Interventional Study on Targeted Therapy for Patients With Unresectable or Metastatic BRAFV600E Mutant Melanoma
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  1. Description of age [ Time Frame: Baseline ]
    Age will be assessed in years (date of the initiation of targeted therapy - date of birth)

  2. Description of Sex [ Time Frame: Baseline ]
    Sex will be described in percentage of Male and Female among the participants

  3. Description of BMI [ Time Frame: Baseline ]
    Weight (in kg) and height (in m) will be combined to report BMI in kg/m2

  4. Description of sociodemographic status: country [ Time Frame: Baseline ]
    The country will be described in number of participants included in each country (France, Portugal, Spain, Belgium, Germany, Italy)

  5. Description of sociodemographic status: education level [ Time Frame: Baseline ]
    The education level will be described by the following distribution of participants: with no degree/Primary education, High school level or equivalent and with college degree (i.e. Bachelor, Master or Doctorate)

  6. Description of sociodemographic status: employment status [ Time Frame: Baseline ]
    The employment status will be described by the following distribution of participants: employed, unemployed, retired and student

  7. Description of sociodemographic status: living place [ Time Frame: Baseline ]
    The living place will be described by the following distribution of participants: living in urban/suburban and in rural

  8. Description of sociodemographic status: family situation [ Time Frame: Baseline ]
    The family situation will be described by the following distribution of participants: living alone, cohabiting or living with family members and other

  9. Description of clinical characteristics of patients: time since initial diagnostic of melanoma [ Time Frame: Baseline ]
    The time since initial diagnostic of melanoma will be assessed in number of years (date of the initiation of targeted therapy - date of initial diagnostic of melanoma)

  10. Description of clinical characteristics of patients: time since metastatic diagnosis [ Time Frame: Baseline ]
    The time since metastatic diagnosis will be assessed in number of years (date of the initiation of targeted therapy - date of metastatic diagnosis)

  11. Description of clinical characteristics of patients: initial/primary site of tumor [ Time Frame: Baseline ]
    The Initial/primary site of tumor will be described by the following distribution of participants: with localization in the upper extremities, head and neck, trunk, lower extremities, mucosal or uvea, unknown localization

  12. Description of clinical characteristics of patients: comorbidities [ Time Frame: Baseline ]
    The comorbidities will be described by the following distribution of participants: with diabetes, hypertension, renal failure, cardiovascular disease, other cancer, autoimmune disease, …

  13. Description of clinical characteristics of patients: prior therapies for melanoma [ Time Frame: Baseline ]
    The prior therapies for melanoma will be described by the following distribution of participants: treated with surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, other


Secondary Outcome Measures :
  1. Assessment of the use of TavieSkin application:number of subscribers who frequently use the application [ Time Frame: Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The use of TavieSkin app will be assessed using the app usage data such as the number of subscribers who frequently use the application

  2. Assessment of the use of TavieSkin application: duration of usage per day [ Time Frame: Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The use of TavieSkin app will be assessed using the app usage data such as the duration of usage per day (in number of minutes per day)

  3. Assessment of the use of TavieSkin application: rate of completed data and completed questionnaires [ Time Frame: Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The use of TavieSkin app will be assessed using the app usage data such as the rate of completed data and completed questionnaires

  4. Assessment of the adherence to treatment [ Time Frame: Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The adherence to treatment will be assessed by describing the effective taken medication. The frequency of treatment interruption and permanent discontinuation as reported by the patient will be described.

  5. Assessment of health-related quality of life. [ Time Frame: Baseline, then every 6 weeks during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The health-related quality of life of patients will be described using the Functional Assessment of Cancer Therapy - Melanoma (FACT-M) score. The score range is 0-172, higher scores mean a better quality of life.

  6. Assessment of the activity and the physical function [ Time Frame: Baseline, then every month during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    Activity and physical function at baseline will be assessed using the World Health Organization (WHO) score

  7. Assessment of Work productivity and activity impairment [ Time Frame: Baseline, then every 2 months during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    Work productivity and activity impairment (WPAI) will be assessed using the Specific Health Problem (SHP) V2.0, the WPAI:SHP questionnaire

  8. Assessment of the patient satisfaction toward the TavieSkin application [ Time Frame: Every 2 months during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The patient satisfaction toward the TavieSkin application will be assessed using the System Usability Scale (SUS) score. The score range is 0-100, higher scores mean a better satisfaction.

  9. Assessment of the patient satisfaction toward the treatment [ Time Frame: Every 2 months during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first ]
    The patient satisfaction toward the treatment will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with BRAF-mutant (documented as per routine practice) unresectable or metastatic melanoma in the target countries (France, Portugal, Belgium, Spain, Germany, Italy) and initiating BRAFi/MEKi combination therapy will be invited by its healthcare provider (i.e. oncologist, dermatologist, nurse…) to use the TavieSkin app during a routine visit.
Criteria

Inclusion Criteria:

Only patients starting to use the TavieSkin app will be eligible for enrollment in the survey.

The patient should meet all the following inclusion criteria to be eligible for participating:

  • Male or female aged ≥18 years at diagnosis of unresectable or metastatic melanoma;
  • Diagnosis of histologically or cytologically confirmed BRAF-mutant melanoma that is metastatic or unresectable, documented as per routine practice
  • Patient having an ongoing prescription of one of the three commercially available BRAFi/MEKi combination therapy, at any line of treatment
  • Patient using the TavieSkin app and having signed an informed consent (e-consent via the app) for data collection , according to local regulations

Exclusion Criteria:

Patients will be excluded from the survey if they fulfil any of the following criteria:

  • Patients with other BRAFi/MEKi combination than those available on the market
  • Patient receiving a BRAFi/MEKi combination in the adjuvant setting
  • Patients under guardianship because of mental illness or any other reason
  • Patients treated with a treatment that is not licensed for local use (including approved BRAFi/MEKi combination associated with another product)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911998


Contacts
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Contact: Abir Tadmouri Sellier, PhD +33 7 72 20 53 70 abir.tadmouri.sellier@pierre-fabre.com

Locations
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Portugal
Hospital Evora Recruiting
Evora, Portugal
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
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Study Chair: Nicolas Meyer, MD, PhD Head of Skin Cancer Unit, Toulouse University Cancer Institute, CHU Larrey et Oncopôle, France
Study Chair: Peter Mohr, MD Department of Dermatology, Elbe Kliniken, Buxtehude, Germany
Additional Information:
Publications:
Arance Fernández, A. M. et al. Epidemiological study to evaluate the prevalence of BRAF V600 mutation in patients (pts) diagnosed with advanced melanoma (AM) in routine clinical practice in Spain. J. Clin. Oncol. 33, e20115-e20115 (2015). DOI:10.1200/jco.2015.33.15_suppl.e20115
Sauro, J. A practical guide to the system usability scale: background, benchmarks & best practices. Denver, CO: Measuring Usability LLC, 2011

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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT04911998    
Other Study ID Numbers: NIS-PFO-2020-3501
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Fabre Medicament:
Melanoma
BRAFV600
Targeted therapy
BRAFi/MEKi
Non-interventional study
Metastatic
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas