Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors

Study Overview
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Brief Summary
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This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.

Official Title
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Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)

Conditions
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Follow-up, Compliance, Patient, Text Messaging, Germ Cell Tumor

Intervention / Treatment
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* Other: short message service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with germ cell tumor. Patient with a mobile phone. Patient on surveillance. Exclusion Criteria: Testicular cancer without germ cell component. Prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable PSA. Cognitive condition that would preclude patient's understanding and completion of study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reminder SMS before appointment<br>SMS before appointment detailing the date of consultation and exams to be performed before | Other: short message service<br>* short message service<br>|
| Active comparator: standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who report optimal compliance to surveillance | Optimal compliance is defined according to the following 2 parameters: The patient comes to all the appointments, on the expected day, AND With all the biological and imaging exams previously scheduled by the physician. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who report intermediate compliance to surveillance | Intermediate compliance is defined according to the following 2 parameters: The patient comes to all the appointments, but in one of the consultations, he delays his scheduled appointment of more than 3 weeks but less than 6 weeks OR Missing a biological or imaging exam. | 1 year | 
| Rate of patients who report a non compliance to surveillance | Non compliance is defined according to the following 3 parameters: The patient misses a consultation, without warning, OR He delays of more than 6 weeks his appointment of consultation, OR At least 2 biological or imaging exams requested by the oncologist are missing from all consultations. | 1 year | 
| Patient satisfaction of sending SMS, in experimental arm | It is evaluated with the following question: do you find that having reminder sms for your appointments and exams is useful? evaluated on a scale of 0 to 10 (0: useless, 10: useful) | 1 year | 
| biological recurrence rate | Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin). | 1 year | 
| Radiological recurrence rate | Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surveillance, compliance, germ cell tumors, short message service