Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.
ESTAUVAL
1 other identifier
interventional
143
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2020
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2025
CompletedMarch 19, 2026
March 1, 2026
5.7 years
July 4, 2018
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Impact of patient quality of life
at 3, 6 and 12 months
Study Arms (2)
With learning workshops
EXPERIMENTALPatients 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.
Without learning workshops
OTHERStandard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.
Interventions
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.
Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Eugène Marquis
Rennes, 35042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aurélie THEBAULT
Centre Eugène Marquis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2018
First Posted
August 29, 2018
Study Start
January 13, 2020
Primary Completion
September 25, 2025
Study Completion
September 25, 2025
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share