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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175344
First received: September 11, 2005
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Scar massage.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form). [ Time Frame: Two years ] [ Designated as safety issue: No ]

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 [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: February 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Arm A: Self-administered massage of the postoperative scar after breast cancer surgery.
Procedure: Scar massage.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175344

Locations
Canada, British Columbia
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, Canada, V8R 6V5
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Pauline Truong, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175344     History of Changes
Other Study ID Numbers: H03-60011
Study First Received: September 11, 2005
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
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.

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Breast Diseases
Neoplasms
Neoplasms by Site
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014