Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors (TEXTIS)
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|ClinicalTrials.gov Identifier: NCT03868176|
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment|
|Follow-up Compliance, Patient Text Messaging Germ Cell Tumor||Other: short message service|
|Study Type :||Observational|
|Estimated Enrollment :||235 participants|
|Official Title:||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)|
|Actual Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: reminder SMS before appointment
SMS before appointment detailing the date of consultation and exams to be performed before
Other: short message service
short message service
|Active comparator: standard of care|
- Rate of patients who report optimal compliance to surveillance [ Time Frame: 1 year ]
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.
- Rate of patients who report intermediate compliance to surveillance [ Time Frame: 1 year ]
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.
- Rate of patients who report a non compliance to surveillance [ Time Frame: 1 year ]
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.
- Patient satisfaction of sending SMS, in experimental arm [ Time Frame: 1 year ]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)
- biological recurrence rate [ Time Frame: 1 year ]Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).
- Radiological recurrence rate [ Time Frame: 1 year ]Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.
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): NCT03868176
|Contact: Elise ROBERTfirstname.lastname@example.org|
|Besançon, Franche-Comté, France, 25030|
|Contact: Elise Robert +381479999 email@example.com|