Trials / Terminated
TerminatedNCT01939210
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Albert Einstein College of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Anxiety
- Depression
- Digestive System Neoplasm
- Lung Neoplasm
- Pain
- Post-Traumatic Stress Disorder
- Psychological Impact of Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Educational Intervention | Participate in breathing training sessions |
| OTHER | Meditation Therapy | Participate in breathing training sessions |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2015-06-01
- Completion
- 2015-12-02
- First posted
- 2013-09-11
- Last updated
- 2018-05-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01939210. Inclusion in this directory is not an endorsement.