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

NCT ID: NCT06500377

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2026-06-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo saliva sample collection

Meditation Therapy

Intervention Type PROCEDURE

Learn breathing only meditation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo saliva sample collection

Meditation Therapy

Intervention Type PROCEDURE

Learn focused attention only meditation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo saliva sample collection

Meditation Therapy

Intervention Type PROCEDURE

Learn mindfulness only meditation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo saliva sample collection

Meditation Therapy

Intervention Type PROCEDURE

Learn breathing, focused attention, and mindfulness combined meditation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo saliva sample collection

Intervention Type PROCEDURE

Meditation Therapy

Learn breathing only meditation

Intervention Type PROCEDURE

Meditation Therapy

Learn focused attention only meditation

Intervention Type PROCEDURE

Meditation Therapy

Learn mindfulness only meditation

Intervention Type PROCEDURE

Meditation Therapy

Learn breathing, focused attention, and mindfulness combined meditation

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Meditation Meditation Meditation Meditation

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard T Lee

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status RECRUITING

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Richard T. Lee

Role: primary

949-671-4091

Richard T. Lee

Role: primary

626-359-8111

Role: backup

626-359-8111

Other Identifiers

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NCI-2024-04827

Identifier Type: REGISTRY

Identifier Source: secondary_id

22607

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22607

Identifier Type: -

Identifier Source: org_study_id

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