Post-SOPHrology Cancer Patients' anxieTY Report

Cancer Clinical Trial

— SOPHTY  

Official title:

Post-SOPHrology Cancer Patients' anxieTY Report

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03707301
• Other study ID #: 2018-0203
• Secondary ID: 2018-A02004-51
• Status: Terminated
• Start date: January 24, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer

Intervention

Other:
• Questionnaires
Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of anxiety difference	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
Secondary	Level of anxiety difference	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 : 7 or less : no symptomatology ; 8 to 10 : doubtful symptomatology ; 11 and more : certain symptomatology.	1 month
Secondary	Level of depression difference	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 : 7 or less : no symptomatology ; 8 to 10 : doubtful symptomatology ; 11 and more : certain symptomatology.	1 month
Secondary	Sessions duration	Duration of sessions will be reported, unit used: minutes.	1 hour
Secondary	Number of sessions	Number of sessions performed during one month will be reported.	1 month
Secondary	Patients satisfaction	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