Clinical trial NCT06500377: Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors
Official title: A Pilot Study Exploring Four Types of Meditation Practices for Relaxation Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Retention rate
timeFrame: Up to 6 weeks
measure: Adherence rate
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Lennar
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Richard T Lee
role: PRINCIPAL_INVESTIGATOR
References: