Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors
TEXTIS
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)
1 other identifier
observational
235
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 8, 2019
March 1, 2019
2.4 years
February 4, 2019
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Rate of patients who report intermediate compliance to surveillance
1 year
Rate of patients who report a non compliance to surveillance
1 year
Patient satisfaction of sending SMS, in experimental arm
1 year
biological recurrence rate
1 year
Radiological recurrence rate
1 year
Study Arms (2)
Experimental: reminder SMS before appointment
SMS before appointment detailing the date of consultation and exams to be performed before
Active comparator: standard of care
Interventions
Eligibility Criteria
235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.
You may qualify if:
- Patient with germ cell tumor.
- Patient with a mobile phone.
- Patient on surveillance.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Besancon
Besançon, Franche-Comté, 25030, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
March 8, 2019
Study Start
February 28, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
March 8, 2019
Record last verified: 2019-03