NCT01667328

Brief Summary

This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable anxiety

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

Study Start

First participant enrolled

June 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

5.8 years

First QC Date

June 14, 2012

Last Update Submit

April 30, 2018

Conditions

AnxietyPresurgical AnxietyBreast Cancer

Keywords

AnxietyPresurgical anxietyBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Anxiety level

    Assessments will be done immediately post registration and immediately prior to surgery

    Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.

Study Arms (2)

Massage therapy

EXPERIMENTAL

This group will received presurgical massage

Procedure: Massage therapy

Control

PLACEBO COMPARATOR

Standard of care with no massage

Procedure: Standard of care

Interventions

Massage therapyPROCEDURE

Presurgical 15 minute massage performed by a licensed massage therapist

Massage therapy
Standard of carePROCEDURE

Control group will receive standard of care with no massage therapy

Control

Eligibility Criteria

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

You may qualify if:

  • Male or female
  • Must speak English
  • Able to give consent
  • years of age or older
  • Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center

You may not qualify if:

  • Anxiolytics or antidepressants medications during the previous 24 hours
  • Any condition that would prohibit receiving a massage
  • IV medications prior to presurgical holding VAS assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

MeSH Terms

Conditions

Anxiety DisordersBreast Neoplasms

Interventions

MassageStandard of Care

Condition Hierarchy (Ancestors)

Mental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Angela Keleher, M.D.

    Vassar Brothers Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

August 17, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2018

Study Completion

March 19, 2018

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)