The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Tissue Reconstruction

April 6, 2015 updated by: Dietlind Wahner-Roedler, Mayo Clinic

The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction - A Pilot Study

In this study we propose to explore the efficacy of massage therapy combined with meditation in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients will be randomized into 2 groups. The first group will consist of massage therapy on 3 consecutive days starting on the 1st day after surgery. The second group will consist of massage therapy combined with meditation for 3 consecutive days starting on the 1st day after surgery. The effect of massage and massage combined with meditation on stress, anxiety, relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood and energy level will be evaluated by using three different surveys.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Besides skin cancer breast cancer is the most common malignancy among women. Most women with breast cancer will undergo some kind of breast cancer surgery. For women undergoing a mastectomy, breast reconstruction offers significant quality of life benefits and is a vital option to enhance breast cancer recovery. There are two general types of reconstructive options:

  1. Prosthetic devices (saline implants, silicone implants, tissue expanders)
  2. Autologous tissue reconstructions with tissue flaps that are transferred from adjoining or distant donor sites to the anterior chest wall.

When reconstruction of the breast mound is accomplished using the patient's own tissues, the result is typically more natural in both appearance and feel than with expander/implant reconstruction. However the disadvantages of autologous reconstruction include longer surgical procedures and prolonged recovery time as compared to prosthetic reconstruction. Postoperative pain, anxiety, fatigue are among the challenges facing patients undergoing breast cancer surgery and especially patients who decided to undergo these complicated plastic surgical procedures. Massage therapy has been used successfully to target common postoperative symptoms such as pain, anxiety, tension and fatigue in breast cancer patients.

Meditation has been shown to be helpful in achieving healing and relaxation through purposeful contemplation and reflection.

In this study we propose to explore the effectiveness of massage therapy combined with meditation in breast cancer patients recovering from autologous tissue reconstruction with the hope that the combination will augment the benefit obtained by massage therapy alone.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18 and above able to give informed consent

  • Women who are undergoing mastectomies for breast cancer and the following autologous tissue reconstruction.

    • Free TRAM flaps (TRAM = Transverse Rectus Abdominis Myocutaneous)
    • Muscle-sparing (MS) free TRAM flaps (or MS-TRAM)
    • DIEP flaps (DIEP = Deep Inferior Epigastric Perforator)
    • SIEA flaps (SIEA = Superficial Inferior Epigastric Artery)
    • Pedicled TRAM flaps
  • Patients who undergo one of these 5 surgeries on a Monday or a Tuesday
  • Able to speak and understand English
  • Able to complete the three questionnaires

Exclusion Criteria:

  • Women who decline to participate in the study
  • Women with any kind of breast reconstruction surgery other than what is listed in the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Massage
Daily massage for 20 minutes the first 3 days following surgery.
Procedure: Massage
Patients will receive a daily 20 minute massage in their hospital room on the first 3 days following surgery.
Active Comparator: Massage combined with meditation
Daily massage for 20 minutes combined with meditation the first 3 days following surgery.
Procedure: Massage combined with meditation
Patients will receive a daily 20 minute massage combined with meditation in their hospital room on the first 3 days following surgery.
Other Names:
  • Meditation
  • Massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Time Frame: 3 Days
3 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the effect of massage therapy combined with meditation on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Time Frame: 3 Days
3 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-008563

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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