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Study of Massage Therapy Within a Brain Tumor Setting

Not Applicable
Completed
Conditions
Brain Tumors
Interventions
Behavioral: Massage Therapy
Registration Number
NCT00873184
Lead Sponsor
Duke University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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.
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Exclusion Criteria
  • N/A
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Massage TherapyA 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.
Primary Outcome Measures
NameTimeMethod
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.6 months
Secondary Outcome Measures
NameTimeMethod
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.12 months

Trial Locations

Locations (1)

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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