- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Saint-Priest-en-Jarez, Frankrike, 42270
- Institut de Cancérologie Lucien Neuwirth
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of anxiety difference
Tidsramme: 1 hour
|
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of anxiety difference
Tidsramme: 1 month
|
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
|
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
|
|
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
|
|
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.
|
1 month
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018-0203 (Annen identifikator: M D Anderson Cancer Center)
- 2018-A02004-51 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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