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

Study Overview
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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.

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.

Official Title
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Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies

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

Intervention / Treatment
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* Other: Educational Intervention
* Other: Meditation Therapy
* Other: Questionnaire Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (breathing training sessions)<br>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. | Other: Educational Intervention<br>* Participate in breathing training sessions<br>* Other names: Intervention, Educational;Other: Meditation Therapy<br>* Participate in breathing training sessions<br>* Other names: Meditation;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (control)<br>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. | Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching | Data will be analyzed using a mixed-model analysis of variance (ANOVA) to test for differences between the two independent groups (with a fixed effect factor of group membership). | Baseline to up to 5 weeks | 
| Changes in gate width |  | Baseline to up to 5 weeks | 
| Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction | Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership). | Baseline to up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment | Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership). | Baseline to up to 5 weeks |