SOPHTY: Post-SOPHrology Cancer Patients' anxieTY Report

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Terminated
CT.gov ID
NCT03707301
Collaborator
Institut de Cancérologie de la Loire (Other)
17
1
27.6
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-SOPHrology Cancer Patients' anxieTY Report
Actual Study Start Date :
Jan 24, 2019
Actual Primary Completion Date :
May 12, 2021
Actual Study Completion Date :
May 12, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Level of anxiety difference [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.

Secondary Outcome Measures

  1. Level of anxiety difference [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 : 7 or less : no symptomatology ; 8 to 10 : doubtful symptomatology ; 11 and more : certain symptomatology.

  2. Level of depression difference [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 : 7 or less : no symptomatology ; 8 to 10 : doubtful symptomatology ; 11 and more : certain symptomatology.

  3. Sessions duration [1 hour]

    Duration of sessions will be reported, unit used: minutes.

  4. Number of sessions [1 month]

    Number of sessions performed during one month will be reported.

  5. Patients satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez France 42270

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne
  • Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT03707301
Other Study ID Numbers:
  • 2018-0203
  • 2018-A02004-51
First Posted:
Oct 16, 2018
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022