Study of Massage Therapy Within a Brain Tumor Setting

Brain Tumors Clinical Trial

Official title:

Feasibility Study of Massage Therapy Within a Brain Tumor Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873184
• Other study ID #: Pro00010000
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: May 29, 2013
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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:

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

Behavioral:
• Massage Therapy
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Massage Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

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