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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Other: Questionnaires

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients performing sophrology sessions at the Lucien Neuwirth Cancer Institute will be recuited in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaires; Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sessions duration	Duration of sessions will be reported, unit used: minutes.	1 hour
Number of sessions	Number of sessions performed during one month will be reported.	1 month
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Anxiety; Sophrology; Hospital Anxiety and Depression scale
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2018-0203 (Other Identifier: M D Anderson Cancer Center); 2018-A02004-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No