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Study of Massage Therapy Within a Brain Tumor Setting

Primary Purpose

Brain Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring massage therapy in patients with brain tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • N/A

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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.

Outcomes

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.

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.

Full Information

First Posted
March 30, 2009
Last Updated
May 29, 2013
Sponsor
Duke University
Collaborators
Massage Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00873184
Brief Title
Study of Massage Therapy Within a Brain Tumor Setting
Official Title
Feasibility Study of Massage Therapy Within a Brain Tumor Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Massage Therapy Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
massage therapy in patients with brain tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Massage Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: > 18 years old Karnofsky Performance Score of > 70 at onset of study estimated life expectancy of > 3 months approval from attending oncologist the ability to speak, read and write English live within a 60 mile radius of the DCL 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: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Keir, Dr.Ph,MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Study of Massage Therapy Within a Brain Tumor Setting

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