Brief Title
Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors
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)
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.
Study Type
Observational
Primary Outcome
Rate of patients who report optimal compliance to surveillance
Secondary Outcome
Rate of patients who report intermediate compliance to surveillance
Condition
Follow-up
Intervention
short message service
Study Arms / Comparison Groups
Experimental: reminder SMS before appointment
Description: SMS before appointment detailing the date of consultation and exams to be performed before
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
235
Start Date
February 28, 2019
Completion Date
August 2021
Primary Completion Date
August 2021
Eligibility 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.
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +381479999, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03868176
Organization ID
P/2018/404
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Besancon
Study Sponsor
, ,
Verification Date
March 2019