- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Saint-Priest-en-Jarez, Frankrike, 42270
- Institut de Cancérologie Lucien Neuwirth
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of anxiety difference
Tidsram: 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.
|
1 hour
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of anxiety difference
Tidsram: 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 :
|
1 month
|
|
Level of depression difference
Tidsram: 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 :
|
1 month
|
|
Sessions duration
Tidsram: 1 hour
|
Duration of sessions will be reported, unit used: minutes.
|
1 hour
|
|
Number of sessions
Tidsram: 1 month
|
Number of sessions performed during one month will be reported.
|
1 month
|
|
Patients satisfaction
Tidsram: 1 month
|
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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018-0203 (Annan identifierare: M D Anderson Cancer Center)
- 2018-A02004-51 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .