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Recruiting NCT06500377

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Meditation Therapy, Meditation Therapy, Meditation Therapy.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study Exploring Four Types of Meditation Practices for Relaxation Among Cancer Survivors

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo saliva sample collection
  • Procedure Meditation Therapy
    Learn breathing only meditation
  • Procedure Meditation Therapy
    Learn focused attention only meditation
  • Procedure Meditation Therapy
    Learn mindfulness only meditation
  • Procedure Meditation Therapy
    Learn breathing, focused attention, and mindfulness combined meditation
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Retention rate [Time frame: Up to 6 weeks]
  • Adherence rate [Time frame: Up to 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • City of Hope Medical Center — Duarte
  • City of Hope at Irvine Lennar — Irvine

Identifiers

NCT: NCT06500377 · 22607 · NCI-2024-04827 · 22607 · P30CA033572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗