Brain Tumors Clinical Trial
Official title:
Feasibility Study of Massage Therapy Within a Brain Tumor Setting
Verified date | March 2012 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Massage Therapy Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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