Post-SOPHrology Cancer Patients' anxieTY Report

NCT03707301 | Terminated

• 2 other identifiers: 2018-02032018-A02004-51
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Sophrology; Anxiety; Hospital Anxiety and Depression scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Level of anxiety difference

  1 month

• Level of depression difference

  1 month

• Sessions duration

  1 hour

• Number of sessions

  1 month

• Patients satisfaction

  1 month

Study Arms (1)

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

Interventions

Questionnaires OTHER

Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.

Cancer patients performing sophrology sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- Patient performing at least one session of sophrology in the Lucien Neuwirth Cancer Institute

You may not qualify if:

• Protected patient (according to the law),
• Patient with incapacity to complete questionnaires,
• Patient with incapacity to perform sophrologic movements.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut de Cancérologie de la Loire: collaborator

Study Sites (1)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stéphanie Morisson, MD

  Institut de Cancérologie Lucien Neuwirth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: January 24, 2019
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)