Guided Meditation for Breast and Gynecologic Cancers

(Med-RT BG Trial)

Overseen By Rachel R. Kingford

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Suicidal ideation, Psychotic state, Unstable illness, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness-guided meditations can reduce anxiety for individuals undergoing radiation therapy for breast or gynecological cancers. Participants will either engage in guided meditation during treatment or continue with usual care. The trial seeks individuals diagnosed with breast or gynecological cancer who are about to receive 15-25 radiation therapy sessions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that guided meditation is safe for patients with breast and gynecologic cancers?

Research has shown that mindfulness and meditation are generally well-tolerated by cancer patients. Studies have found that these practices can improve mental health and overall well-being in women with breast cancer. These studies reported no serious side effects from meditation.

In one study, participants engaged in both group and individual meditation sessions and found them manageable. Another review noted benefits such as reduced anxiety and stress, without any major negative effects. Overall, meditation appears safe to use alongside other cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about guided meditation for breast and gynecologic cancers because it offers a non-invasive, holistic approach that complements traditional treatments like surgery, chemotherapy, and radiation. Unlike these standard treatments, which focus on directly attacking cancer cells, guided meditation aims to improve patients' mental well-being, potentially reducing stress and enhancing overall quality of life during treatment. This approach is unique because it addresses the psychological aspect of cancer treatment, which is often overlooked but crucial for patient recovery and resilience.

What evidence suggests that guided meditation is effective for anxiety during radiation therapy for breast and gynecological cancers?

Research has shown that mindfulness activities, such as guided meditation, can reduce anxiety, depression, and stress in cancer patients. One study on women with breast and gynecologic cancer found significant improvements in these areas. Another review indicated that mindfulness meditation enhanced mood in cancer survivors. In this trial, participants will receive either a Guided Meditation Intervention or Standard of Care. These findings suggest that guided meditation, which participants in this trial may receive, could effectively manage anxiety during radiation therapy for breast and gynecologic cancers. The evidence highlights its potential benefits, particularly for improving emotional well-being in cancer patients. ^{4 5 6 7 8}

Who Is on the Research Team?

Lindsay Burt, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

This trial is for patients undergoing radiation therapy for breast or gynecological cancers who are experiencing anxiety related to their treatment. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

I can care for myself but may not be able to do active work.

I am eligible for 15-25 daily radiation treatments for my breast or gynecological cancer.

Exclusion Criteria

Active suicidal ideation or active psychotic state in the opinion of the investigator

An unstable illness that, in the opinion of the investigator, would interfere with study treatment

Inability to understand and/or speak the English language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy with guided meditation to assess its effect on anxiety

7 weeks

Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guided Meditation

Trial Overview The study is testing the impact of a short, audio-recorded guided meditation practice on patients' anxiety levels during radiation therapy sessions for breast and gynecological malignancies.

How Is the Trial Designed?

Group I: Guided Meditation Intervention Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23775158/

Mindfulness-based cognitive group therapy for women with ... We investigated the effectiveness and acceptability of MBCT for women with breast and gynecologic cancer. ... and complete data were available for 36 women.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07166042

Study Details | NCT07166042 | Guided Meditation During ... Diagnosis of breast or gynelogical cancer. Eligible to receive 15-25 daily radiation therapy treatments for breast or gynelogical cancer.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763425003975

The Effect of Mindfulness-Based Meditation on the Immune ... Eligible studies involved cancer patients (primarily breast cancer, >87%) undergoing mindfulness-based meditation interventions and reporting ...

4. nature.com nature.com/articles/s41598-025-85745-1

An examination of the effectiveness of mindfulness ... Based on the results of this study, it can be concluded that MICBT therapy is effective in reducing depression, anxiety, and stress and ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-02540

Mindfulness and Tai Chi for Cancer Health (MATCH) Study This large, pragmatic trial demonstrated both mindfulness and TCQ interventions improved mood in distressed cancer survivors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00248911

The Effect Of Meditation On Quality Of Life In Women ... Meditation and Breast Cancer: Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6623989/

Evidence for the Role of Mindfulness in Cancer: Benefits and ... In this review article, we present clinical trial data showing the benefits of mindfulness in various aspects of cancer management as well as techniques that ...

8. nrgoncology.org nrgoncology.org/Home/News/Post/nrg-oncology-activates-the-heal-abc-study-harnessing-e-mindfulness-approaches-for-living-after-breast-cancer-nrg-cc015

NRG-CC015 HEAL-ABC: Harnessing E-Mindfulness ... A study to examine mindfulness training to improve mental health and well-being in younger breast cancer survivors, also known as “HEAL-ABC.”