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Clinical Trial Summary

This randomized pilot clinical trial studies the effects of meditation-based breathing training on patients' control of their breathing patterns and breathing-related movement, as well as on their psychological distress and treatment experience during radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress by improving breathing patterns in patients with abdominal or lung cancer undergoing radiation therapy.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the influence of regular breathing cycles using breathing relaxation techniques on efficacy of the respiratory-gated treatment as measured by: (1) real-time position management (RPM) parameters; (2) end inspiration or expiration length; (3) changes in gate width.

SECONDARY OBJECTIVES:

I. To evaluate the effect of breathing relaxation techniques on: (1) psychosocial outcomes; (2) treatment compliance.

OUTLINE:

PHASE I: Patients and staff members complete structured interviews at baseline.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo four dimensional computed tomography (4D-CT) on day 14 and undergo image-guided stereotactic body radiation therapy (SBRT) or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.

ARM II: Patients receive standard care over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.

After completion of study treatment, patients are followed up at 2 or 5 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01939210
Study type Interventional
Source Albert Einstein College of Medicine, Inc.
Contact
Status Terminated
Phase N/A
Start date February 2010
Completion date December 2, 2015

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