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



Status:Terminated
Conditions:Anxiety, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Chronic Pain, Depression, Depression, Psychiatric, Psychiatric
Therapuetic Areas:Musculoskeletal, Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:5/20/2018
Start Date:February 2010
End Date:December 2, 2015

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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.

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.

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
We found this trial at
1
site
1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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mi
from
Bronx, NY
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