Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors

NCT06500377 | Recruiting DMC FDA Device

• 3 other identifiers: 22607NCI-2024-04827P30CA033572
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

Procedure: Biospecimen Collection; Procedure: Meditation Therapy; Other: Questionnaire Administration

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.

Procedure: Biospecimen Collection; Procedure: Meditation Therapy; Other: Questionnaire Administration

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.

Procedure: Biospecimen Collection; Procedure: Meditation Therapy; Other: Questionnaire Administration

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.

Procedure: Biospecimen Collection; Procedure: Meditation Therapy; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo saliva sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (breathing only meditation); Arm I (focused attention only meditation); Arm III (mindfulness only meditation); Arm IV (combined meditation)

Meditation Therapy PROCEDURE

Learn breathing only meditation

Also known as: Meditation

Arm I (breathing only meditation)

Questionnaire Administration OTHER

Ancillary studies

Arm I (breathing only meditation); Arm I (focused attention only meditation); Arm III (mindfulness only meditation); Arm IV (combined meditation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling; Meditation

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard T Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): June 17, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (2)