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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01939210
• Other study ID #: 09-12-392
• Secondary ID: NCI-2013-0112709
• Status: Terminated
• Phase: N/A
• Start date: February 2010
• Est. completion date: December 2, 2015

Study information

• Verified date: May 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2, 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lung Neoplasm
• Lung Neoplasms
• Neoplasms
• Pain
• Post-Traumatic Stress Disorder
• Psychological Impact of Cancer
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Educational Intervention
Participate in breathing training sessions
• Meditation Therapy
Participate in breathing training sessions
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in gate width		Baseline to up to 5 weeks
Primary	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	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