Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?
Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.
1 other identifier
interventional
96
1 country
1
Brief Summary
All patients undergoing breast cancer surgery are left with scars which can significantly affect their physical and psychological well being. Patients with breast cancer, motivated to optimize healing and function, have inquired about the advisability of scar massage after surgery. Although this is a popular technique advocated by physiotherapists and massage therapists to improve pain, range of motion, and scar pliability, there is currently no scientific research to prove the benefits and/or risks of scar massage in breast cancer patients. We propose to study the effect of scar massage on pain, arm function, scar formation, and quality of life in patients with breast cancer. Patients who have had breast cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre will be offered participation in this research study. To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars. In both groups, we will monitor pain, upper body range of motion, scar characteristics and quality of life using standardized criteria for 2 years from the time of surgery. Problems with infections or blood or fluid accumulation at the scar areas will also be monitored. After 2 years, the information collected will be analyzed and compared to see if there are differences in pain, function or quality of life between the two groups. The results from this study will provide scientific proof of whether or not scar massage after surgery is beneficial for patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Feb 2004
Shorter than P25 for phase_3 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
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFebruary 19, 2014
February 1, 2014
2.2 years
September 11, 2005
February 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Two years
Secondary Outcomes (1)
The secondary outcomes are: upper body range of motion, physical parameters of the scar (pliability, scar height, vascularity and pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm circumference measurements) and quality of
Two years
Study Arms (1)
A
EXPERIMENTALArm A: Self-administered massage of the postoperative scar after breast cancer surgery.
Interventions
To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars.
Eligibility Criteria
You may qualify if:
- Patients must be able to provide informed consent and be physically able to perform daily self-administered breast scar massage
- Female or male patients with histologically-confirmed invasive or in situ breast cancer
- Definitive surgery with BCS or mastectomy +/- axillary dissection or sentinel node sampling
- Adequate surgical healing as judged by treating oncologist during pre-enrolment assessment
- Age 18 years or older with ability to provide written informed consent.
- Ability to start massage within 8 weeks from surgery and comply with daily regimen if randomized to the intervention cohort
- Ability to comply with not performing massage if randomized to the control cohort
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R 6V5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pauline Truong, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 15, 2005
Study Start
February 1, 2004
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
February 19, 2014
Record last verified: 2014-02