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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01736605
First received: November 20, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Massage
Procedure: Massage combined with meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline. [ Time Frame: 3 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Massage
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:
  • Massage
  • Meditation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01736605

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01736605     History of Changes
Other Study ID Numbers: 12-008563
Study First Received: November 20, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Massage
Meditation
Breast Cancer
Breast Surgery
Breast Reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014