Can breathing exercises ease distress in young breast cancer survivors?
NCT ID NCT07501637
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?