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Post-SOPHrology Cancer Patients' anxieTY Report (SOPHTY)

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ClinicalTrials.gov Identifier: NCT03707301
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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
Cancer 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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-SOPHrology Cancer Patients' anxieTY Report
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Level of anxiety difference [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 hour ]
    Duration of sessions will be reported, unit used: minutes.

  4. Number of sessions [ Time Frame: 1 month ]
    Number of sessions performed during one month will be reported.

  5. Patients satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients performing sophrology sessions at the Lucien Neuwirth Cancer Institute will be recuited in this study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707301


Contacts
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Contact: Stéphanie Morisson, MD 0477917000 stephanie.morisson@icloire.fr
Contact: Mathilde Gras, Msc 0477917000 mathilde.gras@icloire.fr

Locations
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France
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Stéphanie Morisson, MD    0477917000 ext +33    stephanie.morisson@icloire.fr   
Contact: Mathilde Gras, Msc    0477917000 ext +33    mathilde.gras@icloire.fr   
Principal Investigator: Stéphanie Morisson, MD         
Sub-Investigator: Aurélie Beneton, MD         
Sub-Investigator: Christelle Brosse, MD         
Sub-Investigator: Marie Mattei, IDE         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Stéphanie Morisson, MD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03707301     History of Changes
Other Study ID Numbers: 2018-0203
2018-A02004-51 ( Other Identifier: ANSM )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de la Loire:
Cancer
Sophrology
Anxiety
Hospital Anxiety and Depression scale