- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175344
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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British Columbia
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency - Vancouver Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: A
Arm A: Self-administered massage of the postoperative scar after breast cancer surgery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Time Frame: Two years
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Two years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Two years
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Two years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pauline Truong, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H03-60011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University Hospital, GhentCompletedScar Tissue or Healthy SkinBelgium
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Assiut UniversityNot yet recruitingCesarean Wound; Dehiscence
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Jessa HospitalCompletedScar | Minimally Invasive Cardiac SurgeryBelgium
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Region SkaneCompletedSurgical Site Infection | Patient SatisfactionSweden