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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03868176
Acronym
TEXTIS
Enrollment
235
Registered
2019-03-08
Start date
2019-02-28
Completion date
2021-08-31
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliance, Patient, Follow-up, Germ Cell Tumor, Text Messaging

Keywords

surveillance, compliance, germ cell tumors, short message service

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.

Interventions

short message service

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of patients who report optimal compliance to surveillance1 yearOptimal 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

MeasureTime frameDescription
Rate of patients who report intermediate compliance to surveillance1 yearIntermediate 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 surveillance1 yearNon 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 arm1 yearIt 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 rate1 yearBiological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).
Radiological recurrence rate1 yearRadiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.

Countries

France

Contacts

Primary ContactElise ROBERT
e1robert@chu-besancon.fr+381479999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026