- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03707301
Post-SOPHrology Cancer Patients' anxieTY Report (SOPHTY)
Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology.
Anxiety levels have never been reported before and after sessions. Indeed, the present study wants to report anxiety levels before, after, and one and three weeks after session. Levels of satisfaction will also be reported.
Studieoversigt
Detaljeret beskrivelse
Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology.
Anxiety levels have never been reported before and after sessions. Indeed, the present study wants to report anxiety levels before, after, and one and three weeks after session. Levels of satisfaction will also be reported.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Saint-Priest-en-Jarez, Frankrig, 42270
- Institut de Cancérologie Lucien Neuwirth
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patient performing at least one session of sophrology in the Lucien Neuwirth Cancer Institute
Exclusion Criteria:
- Protected patient (according to the law),
- Patient with incapacity to complete questionnaires,
- Patient with incapacity to perform sophrologic movements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Cancer patients performing sophrology sessions
Cancer patients performing sophrology sessions will be recruited in this study, and will complete questionnaires of satisfaction and the Hospital Anxiety and Depression scale.
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Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Level of anxiety difference
Tidsramme: 1 hour
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Level of anxiety after sophrology session will be compared to the level of anxiety before session, on a visual scale from 0 to 10.
The scale is 10 centimeters long, printed on a paper.
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1 hour
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Level of anxiety difference
Tidsramme: 1 month
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Level of anxiety after a second session of sophrology will be compared to the level of anxiety reported before the first sophrology session, according to the Hospital Anxiety and Depression scale, part A. The part A is composed of seven questions, with a score obtained between 0 and 28. A score between :
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1 month
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Level of depression difference
Tidsramme: 1 month
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Level of depression after a second session of sophrology will be compared to the level of depression reported before the first sophrology session, according to the Hospital Anxiety and Depression scale, part B. The part B is composed of seven questions, with a score obtained between 0 and 28. A score between :
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1 month
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Sessions duration
Tidsramme: 1 hour
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Duration of sessions will be reported, unit used: minutes.
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1 hour
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Number of sessions
Tidsramme: 1 month
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Number of sessions performed during one month will be reported.
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1 month
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Patients satisfaction
Tidsramme: 1 month
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Patients satisfaction will be reported during one month, as many times as they performed sophrology sessions, on a visual scale from 0 to 10.
The scale is 10 centimeters long, printed on a paper.
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1 month
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-0203 (Anden identifikator: M D Anderson Cancer Center)
- 2018-A02004-51 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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