Breath-Body-Mind for Psychological Distress in Breast Cancer Survivors

RA
DB
VG
Overseen ByVinitha Ganesan, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must be taking: Anti-estrogen therapy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a breathing-based group intervention, called Breath-Body-Mind, can reduce stress and improve overall well-being in breast cancer survivors. Researchers compare this approach to a standard education program to determine which is more effective. Suitable participants are breast cancer survivors diagnosed with early-stage breast cancer within the last two years, currently on anti-estrogen therapy, and experiencing significant stress related to their diagnosis and treatment. Participants should be prepared to engage in virtual workshops and group sessions and practice breathing exercises at home. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance stress management techniques for breast cancer survivors.

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

The trial does not specify if you need to stop taking your current medications. However, you must be on anti-estrogen therapy (like tamoxifen or aromatase inhibitors) to participate. If you are on lithium-based medications, you cannot join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Breath-Body-Mind (BBM) program is generally manageable for participants. Studies have found that this breathing-focused program reduces stress and trauma without major side effects. For example, the BREATH trial found that participants experienced less distress with BBM compared to regular care. BBM employs breathing techniques to manage stress and enhance mental health, and evidence suggests it is safe for breast cancer survivors. Although no serious side effects have been reported, individual experiences may vary. Consulting a healthcare provider before starting any new treatment is always important.12345

Why are researchers excited about this trial?

Breath-Body-Mind (BBM) is unique because it offers a holistic approach to managing psychological distress in breast cancer survivors, using techniques like breathing exercises and meditation. Unlike conventional treatments that may rely heavily on medications or psychotherapy, BBM focuses on self-regulation and stress reduction through mind-body practices. Researchers are excited about BBM because it empowers individuals to actively participate in their own emotional healing, potentially enhancing quality of life with minimal side effects.

What evidence suggests that this trial's treatments could be effective for psychological distress in breast cancer survivors?

Research has shown that Breath-Body-Mind (BBM), which involves slow and controlled breathing, can help reduce stress in breast cancer survivors. Studies have found that mindfulness-based methods, like BBM, improve the quality of life for people who have undergone cancer treatment. For instance, the BREATH trial discovered that these techniques significantly lowered stress in breast cancer survivors compared to standard care. Additionally, other mindfulness programs have demonstrated lasting benefits, such as reduced anxiety and depression, and improved mental health for up to two years. These findings suggest that BBM could effectively manage stress in breast cancer survivors. In this trial, participants will engage in the Breath-Body-Mind program to evaluate its effectiveness in reducing psychological distress.23678

Who Is on the Research Team?

RA

Ritu Aneja, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for women aged 18-50 with early-stage (I-III) estrogen-receptor positive breast cancer, within two years of diagnosis, who finished main treatments at least 6 months ago and are on anti-estrogen therapy. Participants must have significant distress, be able to join group sessions online, and commit to home practice.

Inclusion Criteria

I am willing to attend six clinic visits for tests and data uploads over six months.
I am fully active or have only minor physical limitations.
* Eligible patients will be screened for distress using the IES-R scale. Individuals with scores greater than or equal to 24, will be included in the study.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a breath-based group intervention (Breath-Body-Mind) or a survivorship education program for psychological and physiological outcomes

6 months
Regular group sessions

Follow-up

Participants are monitored for changes in psychological distress and other exploratory outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Breath-Body-Mind (BBM)
  • Survivorship education program (SEP)

Trial Overview

The study compares a breath-based mind-body program (Breath-Body-Mind) with a survivorship education program in young breast cancer survivors. Both groups meet virtually in weekly sessions for 8 weeks and monthly up to 6 months. The goal is to see if the programs help reduce stress and improve well-being.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Breath-Body-Mind for Psychological Distress in Breast ...

This project will use multi-source and multimodal data to generate foundational insights into a stress-targeted intervention for an understudied ...

Mind-Body Group Interventions for Psychological Distress in ...

This project will use multi-source and multimodal data to generate foundational insights into a stress-targeted intervention for an understudied ...

Effectiveness of mindfulness-based interventions on quality of ...

Breast cancer survivors frequently experience psychological impairments related to cancer treatment. · Mindfulness-based interventions improve quality of life in ...

BREATH: Web-Based Self-Management for Psychological ...

Access to BREATH reduced distress among BCSs, but this effect was not sustained during follow-up, and this clinical effect was most prominent in ...

Scientific Publications | BREATH-BODY-MIND™

Treatment for the psychological distress from mass disasters is crucial for preventing long-term negative outcomes such as chronic posttraumatic stress disorder ...

Mindfulness-Based Stress Reduction in Breast Cancer ... - PMC

The purpose of this study was to compare the effects of group-delivered mindfulness-based stress reduction as compared to a waitlist control group among breast ...

7.

breath-body-mind.com

breath-body-mind.com/

BREATH-BODY-MIND™ | Evidence-based Integrative Health

In this special free live online stress resilience program, learn unique evidence-based mind-body practices to quickly relieve stress and worry, strengthen your ...

8.

breathbodymindfoundation.org

breathbodymindfoundation.org/

Breath-Body-Mind Foundation | Shifting Global Consciousness

The Breath-Body-Mind Foundation teaches evidence-based, breath-centered techniques to relieve stress, depression, and trauma in adults and children worldwide.