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

Centre Hospitalier Universitaire de Besancon235 enrolled

Overview

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

Enrollment

235

Conditions

Follow-up Compliance, Patient Text Messaging Germ Cell Tumor

Interventions

short message serviceOTHER

short message service

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHU Besancon

Besançon, Franche-Comté, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Rate of patients who report intermediate compliance to surveillance

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.

Time frame: 1 year

Rate of patients who report a non compliance to surveillance

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.

Time frame: 1 year

Patient satisfaction of sending SMS, in experimental arm

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)

Time frame: 1 year

biological recurrence rate

Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).

Time frame: 1 year

Radiological recurrence rate

Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.

Time frame: 1 year

Central Contacts

Elise ROBERT

CONTACT

+381479999 e1robert@chu-besancon.fr

Data from ClinicalTrials.gov

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