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

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 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

NCT ID

NCT03868176

Organization ID

P/2018/404

Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Besancon

Study Sponsor

, , 

Verification Date

March 2019