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Can breathing exercises ease distress in young breast cancer survivors?

NCT ID NCT07501637

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests a virtual group program called Breath-Body-Mind (BBM) that uses slow breathing and gentle movements to help young breast cancer survivors (ages 18-50) cope with psychological distress. Thirty participants will be randomly assigned to either the BBM program or a general survivorship education group. The main goal is to see if a larger trial is feasible, but researchers will also measure changes in distress, fatigue, sleep, and other health markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Breath-Body-Mind (BBM) program (breathing exercises and gentle movements)
What this could lead to
If it works, this could point toward a simple, group-based way to reduce stress and improve quality of life for young breast cancer survivors.
What could go wrong
This is a very small, early feasibility study with only 30 participants. It is not designed to prove the program works, only to see if a larger trial is possible. Results may not apply to all survivors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The inclusion criteria for this study will be BCS who are between 18 and 50 years of age with early-stage breast cancer (stage I-III) treated with curative intent. * They should be within two years of initial diagnosis. * Patients scoring 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale will be accepted. * Patients should have completed chemo, surgery, and/or radiation components of their planned therapy regimen at least 6 months ago; they should be positive for estrogen-receptor breast cancer and currently on anti-estrogen therapy (tamoxifen, aromatase inhibitors: letrozole, anastrozole, exemestane). * 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. * Individuals must also be motivated to attend a 3-day virtual workshop, which requires a total commitment of approximately 12 hours virtually. * They must be willing to participate in a weekly zoom group session for 8-weeks after attending the workshop and then once monthly afterwards up until the 6-month follow up data collection. * They must be willing to do a 10-20-minute daily practice at home, at least 3 times a week, during the 6-month follow-up period. * They should also be prepared for three clinical visits (one hour each) for specimen and blood collection at baseline, week 8, and 6 months, as well as three additional visits (15 minutes each) for wearable data upload. * A subset of participants (n=10) selected for MRI will be screened for claustrophobia and those qualifying (CLQ \<25) will be selected for MRI sub-study (exploratory aim of this study). * If selected for MRI sub-study, two additional clinical visits (one hour each) will be required. Exclusion Criteria: * Male patients are excluded. * Individuals with a recent history (within past three months) of cardiac arrhythmia, unstable or uncontrolled respiratory disorders such as COPD or asthma, or myocardial infarction, angina. * Individuals with a recent history (within past three months) of schizophrenia or bipolar disorder, those currently engaging in active substance abuse involving illicit drugs (excluding marijuana), those experiencing active violent ideation, or those on lithium-based medication regimens will also be excluded. Current or recent (within three months) suicidal impulse or suicide attempt is exclusionary, although suicidal ideation without intent or impulse is not. * Participants with an Eastern Cooperative Oncology Group (ECOG) score of 2 or higher * Breast cancer patients receiving CDK 4/6 inhibitor-based regimens or GnRH antagonist regimens, will not be eligible. * Patients with IES-R scores less than or equal to 23 will be excluded from the study. * Recent surgery (within 3 months) is not excluded unless, in the opinion of the research team, it would substantially interfere with the ability of the person to participate in the intervention. * Prisoners, pregnant women, and non-English-speaking individuals will not be included. * A subset of participants (n=10) selected for MRI will be screened for claustrophobia and those with a tendency towards claustrophobic events (CLQ \>25) will be excluded from MRI scanning.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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