Anxiety, Depression, Digestive System Neoplasm, Lung Neoplasm, Pain, Post-Traumatic Stress Disorder, Psychological Impact of Cancer
Conditions
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.
Interventions
OTHEREducational Intervention
Participate in breathing training sessions
OTHERMeditation Therapy
Participate in breathing training sessions
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
United States
Outcome results
None listed