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Completed

NCT Number: NCT00873184

Study of Massage Therapy Within a Brain Tumor Setting

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • > 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.

Exclusion criteria

  • N/A

Treatment and study plan

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.

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.

    Time frame: 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Massage Therapy Foundation

Registry information

Official study title

Feasibility Study of Massage Therapy Within a Brain Tumor Setting

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2009
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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