Skip to main content
OpenTrials
Completed

NCT Number: NCT01736605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this 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:

  • Prosthetic devices (saline implants, silicone implants, tissue expanders)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Procedure

Patients will receive a daily 20 minute massage in their hospital room on the first 3 days following surgery.

Massage combined with meditation

Procedure

Patients will receive a daily 20 minute massage combined with meditation in their hospital room on the first 3 days following surgery.

Other names: Massage, Meditation

Primary outcomes

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

    Time frame: 3 Days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2012
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.