Breast CancerNCT07501637
Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
A study testing Breath-Body-Mind (BBM) and Survivorship education program (SEP) in people with Breast Cancer, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
This is a two-arm randomized controlled trial (RCT) to determine the feasibility of a larger, fully powered trial in younger ER+ BCS undergoing endocrine therapy in the Deep South and to evaluate preliminary effectiveness of a breath-based group intervention- Breath-Body-Mind (BBM), a trauma-informed program… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breath-Body-Mind (BBM) and Survivorship education program (SEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UAB School of Health Professions
Birmingham, Alabama, 35233
Vinitha Ganesan, PhD, (205) 934-1868, vganesan@uab.edu
- Recruiting
University of Alabama at Birmingham O'Neal Cancer Center
Birmingham, Alabama, 35294
Ritu Aneja, PhD, raneja@uab.edu
About this study
This is a two-arm randomized controlled trial (RCT) to determine the feasibility of a larger, fully powered trial in younger ER+ BCS undergoing endocrine therapy in the Deep South and to evaluate preliminary effectiveness of a breath-based group intervention- Breath-Body-Mind (BBM), a trauma-informed program emphasizing slow-paced coherent resonance breathing on psychological and physiological outcomes. The second arm, a survivorship education program (SEP), will serve as an attention-control to match contact time and group setting to control for placebo effects. This project will use multi-source and multimodal data to generate foundational insights into a stress-targeted intervention for an understudied survivorship population. Outcome measures will be assessed across all arms and will include self-reported measures, fMRI, neuro-endocrine-immune blood markers, multi-omics analyses, and physiological measures through a wrist-worn wearable device (GENEActiv).
Primary outcomes:
Read more
- Feasibility of study as measured by rates of enrollment, randomization, retention, and study completion. We will also develop a data collection system and evaluate its usefulness and ability to scale for a future trial.
Secondary outcomes:
- Change in psychological distress (Impact of Event Scale-Revised, IES-R) related to cancer diagnosis and treatment between baseline and 6 months after workshop.
Exploratory outcomes:
- Fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
- Sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and the GENEActive device
- Pain using the Brief Pain Index (BPI),
- Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS)
- Medication adherence using the Morisky Medication Adherence Scale
- Interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA)
- Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS)
- Neurocognitive function (attention, working memory, processing speed, and executive functioning) using NIH toolbox
- Overall quality of life will be measured using the Whole Person Health Index (WPHI).
- Additional cancer-related outcomes will include the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23 (EORTC QLQ-BR23) body image subscale.
- The Adverse Childhood Experiences Questionnaire (ACE-Q) and the Big Five Inventory-2 Short Form (BFI-2-S) will be used to assess early life stress and personality traits that may moderate response to the intervention.
- Peripheral biomarkers will be measured, including inflammatory cytokines (IL-6, TNF-α), neurotrophic factors (BDNF), neuroendocrine hormones (cortisol, oxytocin), fasting cardiometabolic markers (glucose, insulin), and blood pressure.
- Examine neurobiological mechanisms using resting-state fMRI (brain connectivity changes), and multi-omics profiling (epigenomics, transcriptomics, proteomics, metabolomics).
- Conditions
- Breast Cancer
- Being tested
- Breath-Body-Mind (BBM), Survivorship education program (SEP)
- Keywords
- Breast cancer survivors, Breath-Body-Mind, survivorship education program, psychological distress, fatigue, breast cancer, endocrine therapy
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-Body-Mind (BBM)Behavioural
The BBM program involves a 12-hour structured training provided virtually, 4 hours/day for 3 consecutive days, followed by 8 weeks of once-a-week online group practice (45 min per session) and daily home practice (20 min per day of coherent breathing with some movement practices). From week 9 onwards, online group practice will be offered once a month for 4 months. BBM entails qigong movements and gentle, coherent breathing (also called Resonance Breathing) through the nose at 5 breath cycles per minute (cpm), with an equal length of inhalation and exhalation, optimizing HRV. The BBM workshop teaches participants how to become aware of their psychophysiological states and how to use BBM techniques to balance their stress response systems.
Survivorship education program (SEP)Behavioural
This survivorship education program will serve as the control arm. It comprises informational modules focused on recovery after cancer treatment, including managing fatigue and side effects and navigating follow-up care, communication strategies, body image, and planning for long-term wellness. Control participants will have a contact and data acquisition protocol similar to those in the BBM group. The control intervention will also be administered virtually over 3 consecutive days with the same number of contact hours as the BBM intervention. Participants will be asked to reflect on and apply the strategies discussed (e.g., goal setting, self-monitoring) during an 8-week remote follow-up. Participants will meet once a week with the facilitator online in a group education format to discuss challenges and reinforce learning. From week 9 onwards, online group meetings will be offered once a month for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm receives the Breath-body-mind intervention Receives: Behavioral: Breath-Body-Mind (BBM) |
| Control | Placebo comparator | This arm receives survivorship education program Receives: Behavioral: Survivorship education program (SEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall percentage rate of recruitment.
To assess the overall percentage rate of recruitment.
Measured: baseline, 6 months
Secondary outcomes (1)
Change in psychological distress
Psychological distress will be measured by the Impact of Event Scale-Revised (IES-R). IES-R scale is based on a 22-item scale questionnaire with a cumulative value from 0 to 88, where anything greater than or equal to 24 is considered to have more cancer-related traumatic stress.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start13 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritu Aneja, University of Alabama at Birmingham
- Investigators
- Ritu Aneja, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501637
- Sponsor's protocol ID
- IRB-300016383
- Other IDs
- UAB
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07501637
- Acronym / sponsor ID
- IRB-300016383
- Conditions
- Breast Cancer
- Keywords
- Breast cancer survivors, Breath-Body-Mind, survivorship education program, psychological distress, fatigue, breast cancer, endocrine therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-arm randomized controlled trial (RCT) to determine the feasibility of a larger, fully powered trial in younger ER+ BCS undergoing endocrine therapy in the Deep South and to evaluate preliminary effectiveness of a breath-based group intervention- Breath-Body-Mind (BBM), a trauma-informed program emphasizing slow-paced coherent resonance breathing on psychological and physiological outcomes. The second arm, a survivorship education program (SEP), will serve as an attention-control to match contact time and group setting to control for placebo effects. This project will use multi-source and multimodal data to generate foundational insights into a stress-targeted intervention for an understudied survivorship population. Outcome measures will be assessed across all arms and will include self-reported measures, fMRI, neuro-endocrine-immune blood markers, multi-omics analyses, and physiological measures through a wrist-worn wearable device (GENEActiv).
Primary outcomes:
- Feasibility of study as measured by rates of enrollment, randomization, retention, and study completion. We will also develop a data collection system and evaluate its usefulness and ability to scale for a future trial.
Secondary outcomes:
- Change in psychological distress (Impact of Event Scale-Revised, IES-R) related to cancer diagnosis and treatment between baseline and 6 months after workshop.
Exploratory outcomes:
- Fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
- Sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and the GENEActive device
- Pain using the Brief Pain Index (BPI),
- Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS)
- Medication adherence using the Morisky Medication Adherence Scale
- Interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA)
- Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS)
- Neurocognitive function (attention, working memory, processing speed, and executive functioning) using NIH toolbox
- Overall quality of life will be measured using the Whole Person Health Index (WPHI).
- Additional cancer-related outcomes will include the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23 (EORTC QLQ-BR23) body image subscale.
- The Adverse Childhood Experiences Questionnaire (ACE-Q) and the Big Five Inventory-2 Short Form (BFI-2-S) will be used to assess early life stress and personality traits that may moderate response to the intervention.
- Peripheral biomarkers will be measured, including inflammatory cytokines (IL-6, TNF-α), neurotrophic factors (BDNF), neuroendocrine hormones (cortisol, oxytocin), fasting cardiometabolic markers (glucose, insulin), and blood pressure.
- Examine neurobiological mechanisms using resting-state fMRI (brain connectivity changes), and multi-omics profiling (epigenomics, transcriptomics, proteomics, metabolomics).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Breath-Body-Mind (BBM)This arm receives the Breath-body-mind intervention |
| Control | Placebo comparator | Behavioral: Survivorship education program (SEP)This arm receives survivorship education program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath-Body-Mind (BBM)The BBM program involves a 12-hour structured training provided virtually, 4 hours/day for 3 consecutive days, followed by 8 weeks of once-a-week online group practice (45 min per session) and daily home practice (20 min per day of coherent breathing with some movement practices). From week 9 onwards, online group practice will be offered once a month for 4 months. BBM entails qigong movements and gentle, coherent breathing (also called Resonance Breathing) through the nose at 5 breath cycles per minute (cpm), with an equal length of inhalation and exhalation, optimizing HRV. The BBM workshop teaches participants how to become aware of their psychophysiological states and how to use BBM techniques to balance their stress response systems. | Behavioural | Intervention |
| Survivorship education program (SEP)This survivorship education program will serve as the control arm. It comprises informational modules focused on recovery after cancer treatment, including managing fatigue and side effects and navigating follow-up care, communication strategies, body image, and planning for long-term wellness. Control participants will have a contact and data acquisition protocol similar to those in the BBM group. The control intervention will also be administered virtually over 3 consecutive days with the same number of contact hours as the BBM intervention. Participants will be asked to reflect on and apply the strategies discussed (e.g., goal setting, self-monitoring) during an 8-week remote follow-up. Participants will meet once a week with the facilitator online in a group education format to discuss challenges and reinforce learning. From week 9 onwards, online group meetings will be offered once a month for 4 months. | Behavioural | Control |
Primary outcome
Overall percentage rate of recruitment.
Time frame: baseline, 6 months
To assess the overall percentage rate of recruitment.
1 secondary outcome
Change in psychological distress
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ritu Aneja, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-Body-Mind (BBM) and Survivorship education program (SEP) in people with Breast Cancer, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ritu Aneja Professor, Associate Dean, PhD (205-934-2277, raneja@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall percentage rate of recruitment. (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.