Follow-upTEXTISNCT03868176
Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors
An observational study of Follow-up and Compliance, Patient, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Follow-up, Compliance, Patient, Text Messaging
- What is being tested?
- short message service
- How many people
- 235 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.
Who may be able to join
- Patient with germ cell tumor.
- Patient with a mobile phone.
- Patient on surveillance.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besancon
Besançon, Franche-Comté, 25030
Elise Robert, +381479999, e1robert@chu-besancon.fr
About this study
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)
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.
- Conditions
- Follow-up, Compliance, Patient, Text Messaging, Germ Cell Tumor
- Being tested
- short message service
- Keywords
- surveillance, compliance, germ cell tumors, short message service
- Medical subject headings
- Patient Compliance, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short message serviceOther
short message service
| Study group | Role | What they receive |
|---|---|---|
| Experimental: reminder SMS before appointment | SMS before appointment detailing the date of consultation and exams to be performed before Receives: Other: short message service | |
| Active comparator: standard of care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 1 year
biological recurrence rate
Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).
Measured: 1 year
Radiological recurrence rate
Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start28 Feb 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow-upStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868176
- Sponsor's protocol ID
- P/2018/404
- Acronym
- TEXTIS
- Status last verified
- Mar 2019
- First submitted
- 4 Feb 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03868176
- Acronym / sponsor ID
- TEXTIS / P/2018/404
- Conditions
- Follow-up, Compliance, Patient, Text Messaging, Germ Cell Tumor
- Keywords
- surveillance, compliance, germ cell tumors, short message service
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: reminder SMS before appointment | – | Other: short message serviceSMS before appointment detailing the date of consultation and exams to be performed before |
| Active comparator: standard of care | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.
Key inclusion criteria (3 listed)
- Patient with germ cell tumor.
- Patient with a mobile phone.
- Patient on surveillance.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short message serviceshort message service | Other | Experimental: reminder SMS before appointment |
Primary outcome
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.
5 secondary outcomes
Rate of patients who report intermediate compliance to surveillance
Time frame: 1 year
Rate of patients who report a non compliance to surveillance
Time frame: 1 year
Patient satisfaction of sending SMS, in experimental arm
Time frame: 1 year
biological recurrence rate
Time frame: 1 year
Radiological recurrence rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follow-up and Compliance, Patient, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise ROBERT (+381479999, e1robert@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who report optimal compliance to surveillance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.