Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Depression Digestive System Neoplasm Lung Neoplasm Pain Post-Traumatic Stress Disorder Psychological Impact of Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm I (breathing training sessions)

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 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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in breathing training sessions

Meditation Therapy

Intervention Type OTHER

Participate in breathing training sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (control)

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.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Participate in breathing training sessions

Intervention Type OTHER

Meditation Therapy

Participate in breathing training sessions

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention, Educational Meditation

Eligibility Criteria

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Inclusion Criteria

* PHASE I - PATIENTS: All patients with abdominal tumors who have undergone at least 4 respiratory-gated radiotherapy treatments
* PHASE I - PATIENTS: Full comprehension of English language
* PHASE I - STAFF: All staff who have overseen the delivery of respiratory-gated radiotherapy for at least 6 months
* PHASE I - STAFF: Full comprehension of English language
* PHASE II: All patients with abdominal or lung tumors undergoing a respiratory gating simulation
* PHASE II: Karnofsky performance status \> 60%
* PHASE II: Life expectancy \> 3 months
* PHASE II: No prior radiotherapy to the abdomen/lung
* PHASE II: Full comprehension of English language

Exclusion Criteria

* PHASE I - PATIENTS: Inability to comprehend English language interview questions
* PHASE I - STAFF: Inability to comprehend English language interview questions
* PHASE II: Karnofsky performance status \< 60%
* PHASE II: Prior radiotherapy to the abdomen/lung
* PHASE II: Evidence of progressive or untreated gross disease outside of the abdomen/lung
* PHASE II: Inability to comprehend English language breathing exercise instructions
* PHASE II: Concurrent diagnosis of a significant respiratory disorder which requires the use of oxygen

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No