Study Stopped
lack of funding to hire a dedicated study interventionist
Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy
Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
4 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Feb 2010
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2015
CompletedMay 18, 2018
May 1, 2018
5.3 years
September 6, 2013
May 15, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (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
Baseline to up to 5 weeks
Study Arms (2)
Arm I (breathing training sessions)
EXPERIMENTALPatients 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 II (control)
ACTIVE COMPARATORPatients 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.
Interventions
Participate in breathing training sessions
Participate in breathing training sessions
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alyson Moadel
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 11, 2013
Study Start
February 1, 2010
Primary Completion
June 1, 2015
Study Completion
December 2, 2015
Last Updated
May 18, 2018
Record last verified: 2018-05