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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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lack of funding to hire a dedicated study interventionist
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (breathing training sessions) | Experimental | 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 II (control) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Participate in breathing training sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to up to 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson Moadel | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| Meditation Therapy | Other | Participate in breathing training sessions |
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| Questionnaire Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D004067 | Digestive System Neoplasms |
| D008175 | Lung Neoplasms |
| D010146 | Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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