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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Pain; Anxiety; Digestive System Neoplasm; Post-Traumatic Stress Disorder; Lung Neoplasm; Psychological Impact of Cancer
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Other: Meditation Therapy

Detailed 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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Participate in breathing training sessions; Other Names: Education for Intervention; Intervention, Educational; Other: Meditation Therapy; Participate in breathing training sessions; Other Names: Meditation
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alyson Moadel, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 2, 2015

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Trauma and Stressor Related Disorders; Neoplasms; Lung Neoplasms; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 09-12-392 (Other Identifier: Albert Einstein College of Medicine); P30CA013330 (U.S. NIH Grant/Contract); 09-068 (University of Chicago Comprehensive Cancer Center); NCI-2013-01127 (Registry Identifier: CTRP (Clinical Trial Reporting Program))