Overview

This trial is active, not recruiting.

Conditions anxiety, depression, digestive system neoplasm, lung neoplasm, pain, post-traumatic stress disorder, psychological impact of cancer
Treatments 4-dimensional computed tomography, educational intervention, meditation therapy, questionnaire administration, radiation therapy, stereotactic body radiation therapy
Sponsor Albert Einstein College of Medicine of Yeshiva University
Collaborator National Cancer Institute (NCI)
Start date February 2010
End date June 2015
Trial size 17 participants
Trial identifier NCT01939210, 09-068, 09-12-392, NCI-2013-01127, P30CA013330

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
4-dimensional computed tomography 4D Computed Tomography
Undergo 4D-CT
educational intervention Education for Intervention
Participate in breathing training sessions
meditation therapy Meditation
Participate in breathing training sessions
questionnaire administration
Ancillary studies
radiation therapy Cancer Radiotherapy
Undergo standard radiation therapy
stereotactic body radiation therapy SBRT
Undergo SBRT
(Active Comparator)
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.
4-dimensional computed tomography 4D Computed Tomography
Undergo 4D-CT
questionnaire administration
Ancillary studies
radiation therapy Cancer Radiotherapy
Undergo standard radiation therapy
stereotactic body radiation therapy SBRT
Undergo SBRT

Primary Outcomes

Measure
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
time frame: Baseline to up to 5 weeks
Changes in gate width
time frame: 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
time frame: Baseline to up to 5 weeks

Secondary Outcomes

Measure
Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment
time frame: Baseline to up to 5 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
Principal investigator Alyson Moadel
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.