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Trial record 48 of 663 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03868176
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment
Follow-up Compliance, Patient Text Messaging Germ Cell Tumor Other: short message service

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Study Type : Observational
Estimated Enrollment : 235 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Group/Cohort Intervention/treatment
Experimental: reminder SMS before appointment
SMS before appointment detailing the date of consultation and exams to be performed before
Other: short message service
short message service

Active comparator: standard of care



Primary Outcome Measures :
  1. Rate of patients who report optimal compliance to surveillance [ Time Frame: 1 year ]

    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.


Secondary Outcome Measures :
  1. Rate of patients who report intermediate compliance to surveillance [ Time Frame: 1 year ]

    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.

  2. Rate of patients who report a non compliance to surveillance [ Time Frame: 1 year ]

    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.

  3. Patient satisfaction of sending SMS, in experimental arm [ Time Frame: 1 year ]
    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)

  4. biological recurrence rate [ Time Frame: 1 year ]
    Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).

  5. Radiological recurrence rate [ Time Frame: 1 year ]
    Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868176


Contacts
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Contact: Elise ROBERT +381479999 e1robert@chu-besancon.fr

Locations
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France
CHU Besancon Recruiting
Besançon, Franche-Comté, France, 25030
Contact: Elise Robert    +381479999    e1robert@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03868176     History of Changes
Other Study ID Numbers: P/2018/404
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
surveillance
compliance
germ cell tumors
short message service
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms
Neoplasms by Histologic Type