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

Not Applicable

Terminated

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

• Registration Number: NCT01939210
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-11
• Primary Completion: 2015-06
• Study Completion: 2015-12-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (control)	Questionnaire Administration	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.
Arm I (breathing training sessions)	Educational Intervention	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.
Arm I (breathing training sessions)	Meditation Therapy	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.
Arm I (breathing training sessions)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
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	Baseline to up to 5 weeks	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).
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	Baseline to up to 5 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment	Baseline to up to 5 weeks	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).

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States