Trial Title:
Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors
NCT ID:
NCT06500377
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo saliva sample collection
Arm group label:
Arm I (breathing only meditation)
Arm group label:
Arm I (focused attention only meditation)
Arm group label:
Arm III (mindfulness only meditation)
Arm group label:
Arm IV (combined meditation)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Meditation Therapy
Description:
Learn breathing only meditation
Arm group label:
Arm I (breathing only meditation)
Other name:
Meditation
Intervention type:
Procedure
Intervention name:
Meditation Therapy
Description:
Learn focused attention only meditation
Arm group label:
Arm I (focused attention only meditation)
Other name:
Meditation
Intervention type:
Procedure
Intervention name:
Meditation Therapy
Description:
Learn mindfulness only meditation
Arm group label:
Arm III (mindfulness only meditation)
Other name:
Meditation
Intervention type:
Procedure
Intervention name:
Meditation Therapy
Description:
Learn breathing, focused attention, and mindfulness combined meditation
Arm group label:
Arm IV (combined meditation)
Other name:
Meditation
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (breathing only meditation)
Arm group label:
Arm I (focused attention only meditation)
Arm group label:
Arm III (mindfulness only meditation)
Arm group label:
Arm IV (combined meditation)
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard T. Lee
Phone:
949-671-4091
Email:
richlee@coh.org
Investigator:
Last name:
Richard T. Lee
Email:
Principal Investigator
Facility:
Name:
City of Hope at Irvine Lennar
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard T. Lee
Phone:
626-359-8111
Email:
richlee@coh.org
Contact backup:
Phone:
626-359-8111
Email:
rlee@coh.org
Investigator:
Last name:
Richard T. Lee, MD
Email:
Principal Investigator
Start date:
June 17, 2024
Completion date:
June 17, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500377
