NCT01736605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

November 20, 2012

Last Update Submit

April 6, 2015

Conditions

Breast Cancer

Keywords

MassageMeditationBreast CancerBreast SurgeryBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

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

    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.

    3 Days

Study Arms (2)

Massage

ACTIVE COMPARATOR

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

Procedure: Massage

Massage combined with meditation

ACTIVE COMPARATOR

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

Procedure: Massage combined with meditation

Interventions

MassagePROCEDURE

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

Massage
Massage combined with meditationPROCEDURE

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

Also known as: Massage, Meditation
Massage combined with meditation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MassageMeditation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dietlind L. Wahner-Roedler, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 29, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)