Breast Cancer Trial, Not Yet Recruiting NCT07501637 Sponsor: University of Alabama at Birmingham Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT07501637
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Women aged 18 to 50 who have been diagnosed with early-stage breast cancer (stage I, II, or III) and have been treated with the goal of curing the cancer.
  • People who are within two years of their initial breast cancer diagnosis.
  • People who score 0 or 1 on a standard scale used by doctors to measure how much cancer affects a person's daily activities (called the ECOG scale), meaning they are fully active or have only minor limitations.
  • People who finished chemotherapy, surgery, and/or radiation at least 6 months ago, whose breast cancer is estrogen-receptor positive, and who are currently taking anti-estrogen hormone therapy (such as tamoxifen, letrozole, anastrozole, or exemestane).
  • People who score 24 or higher on a standard questionnaire used to measure stress and emotional distress related to a traumatic event (called the IES-R scale).
  • People who are willing and able to attend a 3-day online workshop requiring approximately 12 hours of participation in total.
  • People who are willing to join a weekly online group video session for 8 weeks after the workshop, followed by monthly sessions up until the 6-month follow-up point.
  • People who are willing to do a 10–20 minute daily practice at home at least 3 times per week throughout the 6-month follow-up period.
  • People who are able to attend three clinic visits (about one hour each) for blood and specimen collection at the start of the study, at week 8, and at 6 months, plus three shorter visits (about 15 minutes each) to upload data from a wearable device.
  • For a small subgroup of 10 participants being considered for an optional brain scan (MRI) part of the study, people who score below 25 on a claustrophobia questionnaire may be selected for that component.
  • If selected for the MRI subgroup, people who are able to attend two additional clinic visits of approximately one hour each.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • Male patients are not eligible for this trial.
  • People who have had a heart rhythm problem, a heart attack, chest pain (angina), or an unstable or uncontrolled breathing condition such as COPD or asthma in the past three months.
  • People who have been diagnosed with schizophrenia or bipolar disorder in the past three months, those currently misusing illicit substances (not including marijuana), those experiencing active thoughts of harming others, those taking lithium-based medications, or those who have had suicidal urges or made a suicide attempt in the past three months (note: having thoughts of suicide without any urge or intent to act on them is not automatically exclusionary — confirm with trial site).
  • People who score 2 or higher on the ECOG scale, meaning their cancer significantly limits their daily activities.
  • Breast cancer patients currently being treated with a type of medication known as CDK 4/6 inhibitors or GnRH antagonists.
  • People who score 23 or lower on the IES-R distress questionnaire.
  • People who have had surgery within the past 3 months, if the research team believes it would significantly affect their ability to take part in the program (confirm with trial site).
  • People who are currently imprisoned, people who are pregnant, and people who do not speak English.
  • For the optional MRI subgroup only: people who score above 25 on the claustrophobia questionnaire would not be eligible for the brain scanning component of the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Ritu Aneja, PhD, University of Alabama at Birmingham

Phone: 205-934-2277

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
31 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall percentage rate of recruitment.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov