- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06500377
Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors
A Pilot Study Exploring Four Types of Meditation Practices for Relaxation Among Cancer Survivors
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
Irvine, California, United States, 92618
- City of Hope at Irvine Lennar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- Provide salivary alpha-amylase sample
- Complete stress tests and study questionnaires
- Be monitored with a Bispectral Index (BIS) device
Exclusion Criteria:
- Inability to complete study required time and procedures as outlined in the study procedures section of the protocol
- Must not have had previous serious illnesses that affect neurological functioning such as strokes, heart attacks, Parkinson disease, etc
- Ongoing active psychiatric condition, depressive/bi-polar related disorders, anxiety, psychosis disorders, or substance use that may interfere with the study including panic disorder, major depression, schizophrenia, and bipolar disease
- Active cancer
- Cancer survivors who have received chemotherapy, radiation therapy, or any other systemic treatment (e.g., hormonal therapy)
- Women who are pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (breathing only meditation)
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.
|
Ancillary studies
Undergo saliva sample collection
Other Names:
Learn breathing only meditation
Other Names:
Learn focused attention only meditation
Other Names:
Learn mindfulness only meditation
Other Names:
Learn breathing, focused attention, and mindfulness combined meditation
Other Names:
|
|
Experimental: Arm I (focused attention only meditation)
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.
|
Ancillary studies
Undergo saliva sample collection
Other Names:
Learn breathing only meditation
Other Names:
Learn focused attention only meditation
Other Names:
Learn mindfulness only meditation
Other Names:
Learn breathing, focused attention, and mindfulness combined meditation
Other Names:
|
|
Experimental: Arm III (mindfulness only meditation)
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.
|
Ancillary studies
Undergo saliva sample collection
Other Names:
Learn breathing only meditation
Other Names:
Learn focused attention only meditation
Other Names:
Learn mindfulness only meditation
Other Names:
Learn breathing, focused attention, and mindfulness combined meditation
Other Names:
|
|
Experimental: Arm IV (combined meditation)
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.
|
Ancillary studies
Undergo saliva sample collection
Other Names:
Learn breathing only meditation
Other Names:
Learn focused attention only meditation
Other Names:
Learn mindfulness only meditation
Other Names:
Learn breathing, focused attention, and mindfulness combined meditation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention rate
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard T Lee, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Relaxation Therapy
- Specimen Handling
- Meditation
Other Study ID Numbers
- 22607 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2024-04827 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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