Study of Massage Therapy Within a Brain Tumor Setting

NCT00873184 | Completed DMC

• 1 other identifier: Pro00010000
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumors

Keywords

massage therapy in patients with brain tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

OTHER

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

Interventions

Massage Therapy BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Duke University: lead
• Massage Therapy Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Massage

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Stephen Keir, Dr.Ph,MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 30, 2013

Record last verified: 2012-03

Locations

US (1)