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

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ClinicalTrials.gov Identifier: NCT01939210
Recruitment Status : Terminated (lack of funding to hire a dedicated study interventionist)
First Posted : September 11, 2013
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alyson Moadel, 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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Digestive System Neoplasm Lung Neoplasm Pain Post-Traumatic Stress Disorder Psychological Impact of Cancer Other: Educational Intervention Other: Meditation Therapy Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
Study Start Date : February 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2, 2015

Resource links provided by the National Library of Medicine


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: Educational Intervention
Participate in breathing training sessions
Other Names:
  • Education for Intervention
  • Intervention, Educational

Other: Meditation Therapy
Participate in breathing training sessions
Other Name: Meditation

Other: Questionnaire Administration
Ancillary studies

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




Primary Outcome Measures :
  1. 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 [ Time Frame: 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).

  2. Changes in gate width [ Time Frame: Baseline to up to 5 weeks ]
  3. Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction [ Time Frame: 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 :
  1. Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939210


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alyson Moadel Albert Einstein College of Medicine

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Responsible Party: Alyson Moadel, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01939210     History of Changes
Other Study ID Numbers: 09-12-392
NCI-2013-01127 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-068
09-12-392 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Neoplasms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Lung Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Trauma and Stressor Related Disorders
Mental Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases