TEXTIS: Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Rate of patients who report optimal compliance to surveillance [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.
Secondary Outcome Measures
- Rate of patients who report intermediate compliance to surveillance [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 [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 [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 [1 year]
Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).
- Radiological recurrence rate [1 year]
Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Besancon | Besançon | Franche-Comté | France | 25030 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P/2018/404