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Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Scar massage.
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, scar massage, breast conserving surgery, scar pain, quality of life, Breast cancer treated with breast conserving surgery with or without axillary dissection or sentinel node sampling.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer Agency - Vancouver Island

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Arm A: Self-administered massage of the postoperative scar after breast cancer surgery.

Outcomes

Primary Outcome Measures

The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2005
Last Updated
February 18, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00175344
Brief Title
Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?
Official Title
Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, scar massage, breast conserving surgery, scar pain, quality of life, Breast cancer treated with breast conserving surgery with or without axillary dissection or sentinel node sampling.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Arm A: Self-administered massage of the postoperative scar after breast cancer surgery.
Intervention Type
Procedure
Intervention Name(s)
Scar massage.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Time Frame
Two years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Truong, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency - Vancouver Island
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada

12. IPD Sharing Statement

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Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?

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