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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline.

Outcome Time Frame:

3 Days

Safety Issue:

No

Principal Investigator

Dietlind L. Wahner-Roedler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-008563

NCT ID:

NCT01736605

Start Date:

January 2013

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Massage
  • Meditation
  • Breast Cancer
  • Breast Surgery
  • Breast Reconstruction
  • Breast Neoplasms

Name

Location

Mayo Clinic Rochester, Minnesota  55905