Clinical trial NCT01939210: Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy
Official title: Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Depression
Digestive System Neoplasm
Lung Neoplasm
Pain
Post-Traumatic Stress Disorder
Psychological Impact of Cancer
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

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
timeFrame: Baseline to up to 5 weeks
measure: Changes in gate width
timeFrame: Baseline to up to 5 weeks
measure: Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction
timeFrame: 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
timeFrame: Baseline to up to 5 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alyson Moadel
role: PRINCIPAL_INVESTIGATOR
References: