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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Surgery
• Intervention / Treatment: Other: Learning workshops; Other: Standard follow-up

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie THEBAULT; Phone Number: +33 2 99 25 30 00; Email: a.thebault@rennes.unicancer.fr
• Study Contact Backup: Name: JOLAINE Valérie; Phone Number: 0299253036; Email: v.jolaine@rennes.unicancer.fr

Study Locations

• France
  • Rennes, France, 35042
    • Recruiting
    • Centre Eugene Marquis
    • Contact: Aurélie THEBAULT; Phone Number: +33 2 99 25 30 00; Email: a.thebault@rennes.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With learning workshops; 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.	Other: Learning workshops; 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.
Other: Without learning workshops; Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.	Other: Standard follow-up; Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery	Number of patients with chronic pain	For 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of patient quality of life	Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale	at 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Investigators: Principal Investigator: Aurélie THEBAULT, Centre Eugene Marquis

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Self massages and self stretching; Workshops for self massages and stretching learning
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2015-4-6-003

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