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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04827 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22607 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial compares the impact of four types of meditation practices, breathing only, focused attention only, mindfulness only, and breathing, focused attention and mindfulness combined, for relaxation in cancer survivors. Studies show that many patients with cancer experience stress and anxiety. Meditation therapy uses a variety of techniques, such as breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer. The trial is being done to find out how meditation can help cancer survivors feel relaxed and attain a peaceful state of mind.
PRIMARY OBJECTIVE:
I. Assess the feasibility to attend and complete the meditation program as scheduled (combined arms) within six weeks.
EXPLORATORY OBJECTIVES:
I. Assess the ability of breathing, mindfulness, focused attention, and a combination of all three meditation techniques to enhance relaxation in cancer survivors.
II. Determine which meditation technique improves the outcome measures the most.
III. Explore which meditation method is preferred by the subjects.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients learn breathing only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.
ARM II: Patients learn focused attention only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.
ARM III: Patients learn mindfulness only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.
ARM IV: Patients learn breathing, focused attention, and mindfulness combined meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (breathing only meditation) | Experimental | Patients learn breathing only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study. |
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| Arm I (focused attention only meditation) | Experimental | Patients learn focused attention only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study. |
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| Arm III (mindfulness only meditation) | Experimental | Patients learn mindfulness only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study. |
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| Arm IV (combined meditation) | Experimental | Patients learn breathing, focused attention, and mindfulness combined meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo saliva sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Retention rate | Feasibility will be achieved if 70% of all enrolled participants attend at least 5 full visits within 6 weeks. Descriptive statistics will be generated. | Up to 6 weeks |
| Adherence rate | Feasibility will be achieved if 70% of all enrolled participants complete all assessments of the program within 6 weeks. Descriptive statistics will be generated. | Up to 6 weeks |
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Inclusion Criteria:
Documented written informed consent of the participant
Age: ≥ 18 years
Ability to understand and fluently speak English or Spanish
No previous training in mind-body relaxation techniques including meditation, yoga, tai chi, qigong, guided imagery, mindfulness-based stress reduction, hypnosis, or cognitive behavior therapy, that exceeds 3 hours. Additionally, no regular practice of mind-body relaxation techniques, or formal experience with mind-body relaxation techniques within the past 12 months
Visual Analog Scale (VAS) anxiety score of > 3 from a range from 0 to 10. A "0" means the lowest anxiety score and a "10" means the highest anxiety score
Long-term cancer survivors who received surgery to treat their cancer ( > 6 months since last treatment) with no history of chemotherapy, radiation therapy, or other systemic therapy (e.g., hormonal therapy) and/or have completely recovered from surgery OR patients identified as having pre-cancerous lesions that have been surgically treated (e.g., colon polyp that has been removed)
Willingness to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Meditation Therapy | Procedure | Learn breathing only meditation |
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| Meditation Therapy | Procedure | Learn focused attention only meditation |
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| Meditation Therapy | Procedure | Learn mindfulness only meditation |
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| Meditation Therapy | Procedure | Learn breathing, focused attention, and mindfulness combined meditation |
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| Questionnaire Administration | Other | Ancillary studies |
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| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| 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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