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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736605
• Other study ID #: 12-008563
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: April 6, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline.		3 Days	No
Secondary	Assess the effect of massage therapy combined with meditation on pain and stress related symptoms after breast reconstruction surgery compared to baseline.		3 Days	No