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Study of Massage Therapy Within a Brain Tumor Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873184
First Posted: April 1, 2009
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massage Therapy Foundation
Information provided by (Responsible Party):
Duke University
  Purpose

The purpose of this study is

  • to assess the feasibility and acceptability of massage therapyto examine the effects of massage therapy
  • to explore whether psychological outcomes are associated with changes in patient reported QoL.

Condition Intervention
Brain Tumors Behavioral: Massage Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Massage Therapy Within a Brain Tumor Setting

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To assess the feasibility and acceptability of massage therapy provided to primary brain tumor patients. This assessment will integrate data about patient eligibility rates, patient participation rates, patient adherence rates, and adverse events. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To examine the effects of massage therapy on psychological outcomes related to stress, distress, anxiety, and depression in this population and to explore whether psychological outcomes are associated with changes in patient reported QoL. [ Time Frame: 12 months ]

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
A prospective, single-arm intervention study, potential participants will be identified and screened for eligibility via medical record review of patient scheduled for their post surgical primary adjuvant treatment consultation at DUMC.
Behavioral: Massage Therapy
The setting for massage intervention will take place at The Duke Center for Living (DCL). . The massage therapists at the DCL work closely with physicians to design appropriate interventions for patients who are receiving treatment at DUMC, including cancer patients. All DCL therapists have completed more than 600 hours of training, are nationally certified and hold a North Carolina license to practice massage. These types include Swedish, deep muscle, myofascial release, trigger point, acupressure, Bowen Technique, sports massage and chair massage.

Detailed Description:
As a part of this study, we will provide massage therapy to brain tumor patients. Our contribution here is expected to determine whether massage therapy is safe and helps to improve patient QoL. This contribution is significant because it is expected to provide pilot data on effect sizes so that we may design an adequately powered study to develop massage therapy programs and interventions for patients with brain tumors. In addition to benefiting brain tumor patients, the information from this study may be applied to improving the QoL of other cancer patients.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histological confirmed, newly diagnosed, post surgical WHO grade III/IV malignant glioma (i.e., glioblastoma, anaplastic astrocytoma) being followed at the Preston Robert Tisch Brain Tumor Center (PRT-BTC) at Duke University Medical Center (DUMC) will be considered potential participants for this study.
  • Additional eligibility criteria will be:

    1. > 18 years old
    2. Karnofsky Performance Score of > 70 at onset of study
    3. estimated life expectancy of > 3 months
    4. approval from attending oncologist
    5. the ability to speak, read and write English
    6. live within a 60 mile radius of the DCL
    7. be identified as "stressed" by Perceived Stress Scale (PSS) score, > 12.1 and 13.7 for men and women respectively, and 8) signed informed consent prior to initiation of study-related procedures.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873184


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Massage Therapy Foundation
Investigators
Principal Investigator: Stephen Keir, Dr.Ph,MPH Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00873184     History of Changes
Other Study ID Numbers: Pro00010000
First Submitted: March 30, 2009
First Posted: April 1, 2009
Last Update Posted: May 30, 2013
Last Verified: March 2012

Keywords provided by Duke University:
massage therapy in patients with brain tumors

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases