Mind-Body Group Interventions for Young Breast Cancer Survivors
This study is looking at two group programs for young women (ages 18-50) who have had early-stage breast cancer and are within two years of diagnosis. One program is called Breath-Body-Mind (BBM), which teaches breathing and movement practices. The other is a Survivorship Education Program (SEP) that provides information on recovery after cancer treatment. The goal is to see if these programs are practical to offer on a larger scale and to understand their early effects on stress and well-being. This study will enroll 30 participants. We will measure how many people join the study to understand its feasibility.
- Study design
- This is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. It plans to enroll 30 participants.
- What's involved
- The Breath-Body-Mind program involves 12 hours of virtual training over 3 days, followed by 8 weeks of once-a-week online group practice and daily home practice. The Survivorship Education Program involves informational modules.
- Compensation
- Not stated in the trial record.
- Follow-up
- Recruitment will be measured at baseline and 6 months.
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NCT07501637
Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
Not Yet Recruiting
NAAges 18–50InterventionalSupportive careUniversity of Alabama at BirminghamInvestigator-initiated
~30 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Breath-Body-Mind (BBM)Survivorship education program (SEP)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall percentage rate of recruitment.
Measured over baseline, 6 months
Conditions
Where it's being run
1 sites across 1 statesAlabama1
Study leadership
- Ritu Aneja, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Overall percentage rate of recruitment.baseline, 6 months
To assess the overall percentage rate of recruitment.