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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

Primary Purpose

Anxiety, Depression, Digestive System Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Meditation Therapy
Questionnaire Administration
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (breathing training sessions)

Arm II (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Changes in gate width
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).

Secondary Outcome Measures

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).

Full Information

First Posted
September 6, 2013
Last Updated
May 15, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01939210
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of funding to hire a dedicated study interventionist
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Digestive System Neoplasm, Lung Neoplasm, Pain, Post-Traumatic Stress Disorder, Psychological Impact of Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (breathing training sessions)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Participate in breathing training sessions
Intervention Type
Other
Intervention Name(s)
Meditation Therapy
Other Intervention Name(s)
Meditation
Intervention Description
Participate in breathing training sessions
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline to up to 5 weeks
Title
Changes in gate width
Time Frame
Baseline to up to 5 weeks
Title
Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction
Description
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).
Time Frame
Baseline to up to 5 weeks
Secondary Outcome Measure Information:
Title
Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment
Description
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).
Time Frame
Baseline to up to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson Moadel
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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