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

NCT ID: NCT01736605

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Massage

Daily massage for 20 minutes the first 3 days following surgery.

Group Type ACTIVE_COMPARATOR

Massage

Intervention Type PROCEDURE

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

Massage combined with meditation

Daily massage for 20 minutes combined with meditation the first 3 days following surgery.

Group Type ACTIVE_COMPARATOR

Massage combined with meditation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Massage

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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Massage Meditation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dietlind Wahner-Roedler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dietlind L. Wahner-Roedler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-008563

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.