Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer

June 29, 2017 updated by: Russell Phillips, Beth Israel Deaconess Medical Center

Body-Based Complementary Therapies for Patients With Cancer

RATIONALE: Massage therapy may help relieve symptoms associated with cancer. It is not yet known which type of massage therapy is more effective in treating the symptoms of patients with cancer.

PURPOSE: This randomized clinical trial is studying different types of massage therapy to compare how well they work in treating the symptoms of patients with locally advanced or metastatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the safety and tolerated dose (i.e., duration, techniques, and degree of pressure) of professional massage therapy vs professional simple presence (no touch) massage therapy vs usual care followed by caregiver massage therapy vs usual care in patients with locally advanced or metastatic cancer.
  • Correlate these therapies with pain, anxiety, depression, nausea, and shortness of breath in these patients.
  • Correlate these therapies with patient quality of life and caregiver anxiety and depression.
  • Determine the feasibility of teaching family caregivers how to provide massage therapy and the subsequent use of massage by the caregivers.
  • Determine the effects of caregiver massage therapy on patients and caregivers.
  • Determine the feasibility and acceptability among patients and massage therapists of a simple presence (no touch) massage therapy control group.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I (professional massage therapy): Hospitalized patients are offered massage therapy by a licensed massage therapist for 15-45 minutes once daily for the duration of their hospital stay. Outpatient oncology clinic patients are offered home-based massage therapy by a licensed massage therapist for 15-45 minutes once daily for 3 days.
  • Arm II (usual care): Patients receive usual care for symptom management.
  • Arm III (professional simple presence [no touch] massage therapy): Hospitalized patients are offered simple presence (no touch) massage therapy comprising a room visit by a licensed massage therapist who places his/her hands 12 inches over the patient without direct touch for 15-45 minutes. Treatment is offered once daily for the duration of the hospital stay. Outpatient oncology clinic patients are offered home-based simple presence (no touch) massage therapy by a licensed massage therapist for 15-45 minutes once daily for 3 days.

All patients are then randomized (a second time) to 1 of 2 treatment arms.

  • Arm I (caregiver massage therapy): Previously hospitalized patients are offered home-based caregiver massage therapy for 1 month. Outpatient oncology clinic patients are offered home-based caregiver massage therapy for 3 weeks.
  • Arm II (usual care): Patients receive usual care for symptom management. Hospitalized patients complete a questionnaire addressing symptoms, quality of life, satisfaction with symptom control, and time spent up or out of bed once daily on days 1-5, every 3 days while in the hospital, and then at 1 week, 2 weeks, and 1 month after discharge from the hospital. Outpatient oncology clinic patients complete a similar telephone questionnaire at baseline, 1 week, and then at 1 month.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Solid cancer with evidence of metastases
  • Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
  • Must reside ≤ 25 miles from BIDMC

Exclusion criteria:

  • Patient to sick to be interviewed
  • Absence of severe symptoms
  • Participating in another trial
  • Language barrier
  • MD does not provide permission
  • Expired prior to consent process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: massage

Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.

Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: management of therapy complications
Procedure: massage therapy
Procedure: pain therapy
Active Comparator: no-touch control
Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: management of therapy complications
Procedure: massage therapy
Procedure: pain therapy
No Intervention: Usual care
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: From baseline to 1 week and from baseline to one month
0=no pain to 10=most severe pain
From baseline to 1 week and from baseline to one month
Anxiety
Time Frame: From baseline to 1 week and from baseline to 1 month
0=no anxiety to 10=most severe anxiety
From baseline to 1 week and from baseline to 1 month
Alertness
Time Frame: From baseline to 1 week and from baseline to 1 month
0=not at all alert to 10=most alert
From baseline to 1 week and from baseline to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life: Physical Well-being
Time Frame: From baseline to 1 week and from baseline to 1 month
Physical well-being over past 2 days (0= physically terrible to 10= physically well)
From baseline to 1 week and from baseline to 1 month
Quality of Life: Psychological Well-being
Time Frame: From baseline to 1 week and from baseline to 1 month
Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)
From baseline to 1 week and from baseline to 1 month
Quality of Life: McGill Total
Time Frame: From baseline to 1 week and from baseline to 1 month
Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)
From baseline to 1 week and from baseline to 1 month
Sleep
Time Frame: From baseline to 1 week and from baseline to 1 month
Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep
From baseline to 1 week and from baseline to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Russell S. Phillips, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2004

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2003P000299
  • CDR0000445117 (Registry Identifier: PDQ (Physician Data Query))
  • R21CA098487 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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