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Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops. (ESTAUVAL)

Primary Purpose

Breast Cancer, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard follow-up
Learning workshops
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Self massages and self stretching, Workshops for self massages and stretching learning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman
  • Local development of breast cancer, every stages except stage IV
  • Indication of surgery whatever surgery type except breast reconstruction
  • Age between 18 and 70 years
  • Life expectancy > 12 months assessed by surgeon or pain specialist
  • Informed and written consent
  • Affiliated to a social security system

Exclusion Criteria:

  • History of chronic pain
  • History of shoulder pain
  • Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
  • Geographical constraint (home > 50 km)
  • History of breast surgery
  • Pregnant or lactating woman
  • Protected adult or deprived of her liberty

Sites / Locations

  • Centre Eugène MarquisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

With learning workshops

Without learning workshops

Arm Description

Patients in experimental arm will attend learning workshops, one before breast cancer surgey and one after surgery. Patients will be educated by physiologist to self massages and self stretching. Each workshop will last around 2 hours.

Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.

Outcomes

Primary Outcome Measures

Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery
Number of patients with chronic pain

Secondary Outcome Measures

Impact of patient quality of life
Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale

Full Information

First Posted
July 4, 2018
Last Updated
March 28, 2023
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT03651973
Brief Title
Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.
Acronym
ESTAUVAL
Official Title
Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain. 144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups. Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed. In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching. The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery
Keywords
Self massages and self stretching, Workshops for self massages and stretching learning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With learning workshops
Arm Type
Experimental
Arm Description
Patients in experimental arm will attend learning workshops, one before breast cancer surgey and one after surgery. Patients will be educated by physiologist to self massages and self stretching. Each workshop will last around 2 hours.
Arm Title
Without learning workshops
Arm Type
Other
Arm Description
Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.
Intervention Type
Other
Intervention Name(s)
Standard follow-up
Intervention Description
Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group
Intervention Type
Other
Intervention Name(s)
Learning workshops
Intervention Description
Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.
Primary Outcome Measure Information:
Title
Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery
Description
Number of patients with chronic pain
Time Frame
For 12 months after surgery
Secondary Outcome Measure Information:
Title
Impact of patient quality of life
Description
Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale
Time Frame
at 3, 6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman Local development of breast cancer, every stages except stage IV Indication of surgery whatever surgery type except breast reconstruction More than18 years Life expectancy > 12 months assessed by surgeon or pain specialist Informed and written consent Affiliated to a social security system Exclusion Criteria: History of chronic pain History of shoulder pain Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators, History of breast surgery Pregnant or lactating woman Protected adult or deprived of her liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie THEBAULT
Phone
+33 2 99 25 30 00
Email
a.thebault@rennes.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
JOLAINE Valérie
Phone
0299253036
Email
v.jolaine@rennes.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie THEBAULT
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie THEBAULT
Phone
+33 2 99 25 30 00
Email
a.thebault@rennes.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.

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