Study of Massage Therapy Within a Brain Tumor Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of Massage Therapy Within a Brain Tumor Setting

Conditions
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Brain Tumors

Intervention / Treatment
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* Behavioral: Massage Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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massage therapy in patients with brain tumors