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Feasibility Study of Massage Therapy Within a Brain Tumor Setting


N/A
18 Years
N/A
Not Enrolling
Both
Brain Tumors

Thank you

Trial Information

Feasibility Study of Massage Therapy Within a Brain Tumor Setting


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Stephen Keir, Dr.Ph,MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00010000

NCT ID:

NCT00873184

Start Date:

September 2008

Completion Date:

August 2010

Related Keywords:

  • Brain Tumors
  • massage therapy in patients with brain tumors
  • Brain Neoplasms

Name

Location

Duke University Medical Center Durham, North Carolina  27710