Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03948724
Other study ID # ICO-2019-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 11, 2019
Est. completion date February 2024

Study information

Verified date August 2023
Source Institut Cancerologie de l'Ouest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI


Description:

This study aims to highlight the impact of Patient Therapeutic Education (TPE) in oncology. TPE is an integral part of the care pathway for patients with a chronic pathology such as diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular diseases requiring anticoagulants, haemophilia, renal failure, HIV infection, autoimmune diseases etc.... front of therapeutic progress, many cancers are now taken for a chronic disease. In oncology, TPE starts to grow. Indeed, TPE makes the patient more autonomous, which could reduce the occurrence and / or aggravation of some toxicities, improve the quality of life, the effectiveness of treatment and optimize health costs. Therefore, it is important to develop programme of therapeutic education in oncology. The toxicity of ICI is unusual and sometimes lethal. This toxicity must be recognized and managed quickly to maintain a satisfactory dose-intensity. TPE finds its place by raising awareness among patient to the occurrence of these toxicities. This randomized TPE versus standard care study project will assess the contribution of education in the management of severe toxicities. The investigators believe that changes in patient behaviour will reduce the number of toxicities ≥3 in the TPE arm.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 411
Est. completion date February 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI - Patient who has never received treatment by ICI - Informed patient who signed his consent - Age > or = 18 years - Social insurance Exclusion Criteria: - Patient receiving corticosteroid or immunosuppressant 14 days before inclusion - Immunocompromised patient - Uncontrolled brain metastases - Refusal to participate, patient protected by guardianship - Patient unable to understand the study or unable to follow the education sessions

Study Design


Intervention

Behavioral:
Therapeutic education program
Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment
Usual Information
Patient receive usual informations

Locations

Country Name City State
France Chu Angers Angers
France Institut de Cancerologie de L'Ouest Angers
France Centre Francois Baclesse Caen
France Centre D'Oncologie Et de Radiotherapie 37 Chambray-lès-Tours
France Chd Vendee La Roche-sur-Yon
France Centre Oscar Lambret Lille
France Centre Leon Berard Lyon
France Institut Curie Paris
France Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the number of patients with at least one grade = 3 immune-related Adverse Event (irAE) toxicity for 25 weeks after initiation of ICI treatment between both arm Measure of the number of patients with at least one immune-related Adverse Event (irAE) grade = 3 (CTCAE v5.0) for 25 weeks following the beginning of ICI treatment. 36 months
Secondary Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) Description of immune-related Adverse Event of grade> 2 36 months
Secondary Quantification of ICI treatment received Description of each cycle of ICI 36 months
Secondary Measuring the level of knowledge of patients related to the disease, the treatment and its side effects Measuring the level of knowledge of patients with a specific questionnaire 36 months
Secondary Patients' quality of life assessment: Hospital Anxiety and Depression Scale quality of life evaluated with the Hospital Anxiety and Depression Scale 36 months
Secondary Patients' quality of life assessment: questionnaire-C30 quality of life evaluated with the Quality-of-life questionnaire-C30 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2