Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175344
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2005-09-11
Brief Title:
Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
Detailed Description:
This is a prospective randomized controlled trial design Women who have undergone breast cancer surgery breast conserving surgery or mastectomy and who meet the eligibility criteria specified will be offered study participation After obtaining informed consent subjects will be randomized between two cohorts scar massage intervention group versus no scar massage control group The primary outcome is scar-related pain scored using the McGill Pain Questionnaire Short Form 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 life using the Functional Assessment of Cancer Therapy FACT-B breast cancer-specific instrument
A sample size of 143 patients per arm was estimated to detect a 30 difference in the primary outcome of postoperative scar-related pain between the intervention and the control groups with 80 statistical power
A sample size of 143 patients per arm was estimated to detect a 30 difference in the primary outcome of postoperative scar-related pain between the intervention and the control groups with 80 statistical power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None