Study of Massage Therapy Within a Brain Tumor Setting

Duke University

Status: Completed

Conditions: Brain Tumors

Treatments: Behavioral: Massage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00873184

Pro00010000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1

Other group

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.

Treatment:

Behavioral: Massage Therapy