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

Albert Einstein College of Medicine

Status: Terminated

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

Treatments: Other: Questionnaire Administration; Other: Educational Intervention; Other: Meditation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01939210

P30CA013330 (U.S. NIH Grant/Contract)

09-12-392 (Other Identifier)

09-068

NCI-2013-01127 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Arm I (breathing training sessions)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Meditation Therapy

Other: Educational Intervention

Arm II (control)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration