Remotely Delivered Stress Management for Breast Cancer Survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial examines a remote, group-based stress management program (R-CBSM) delivered via video conferencing to breast cancer survivors. Participants are women aged 50+ who completed primary treatment for Stage I-III breast cancer and are on adjuvant endocrine therapy. The study compares the remotely delivered program to standard survivorship care planning to see if it helps manage distress and related symptoms. The intervention combines relaxation techniques, cognitive behavioral strategies, and coping skills training in a supportive online setting. Recruitment targets English- or Spanish-speaking participants meeting eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 50 yrs or older
* Speaks and reads English or Spanish at 6th grade level
* Diagnosed and completed primary treatment for Stage I-III HR + estrogen/ progesterone + (ER/PR)
* Human Epidermal Growth Factor Receptor 2 (Her2neu)- breast cancer 3 - 12 months prior
* Post-menopausal (\> 12 months since last menstrual cycle)
* Elevated distress (Impact of Event Scale-intrusive thoughts \[IES-I\] \> 14 or elevated distress based on assessment of PI
* If prescribed anti-depressants or anxiolytics on similar regimen \> 2 months.
* Undergoing treatment with Adjuvant Endocrine Therapy (AET)
* Participants may or may not have received chemotherapy or radiation during primary treatment

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Diagnosis with metastatic disease, HER2neu+ or Triple Negative breast cancer
* Prior cancer diagnosis (with the exception of non-melanoma skin cancer) in the 2 years prior to the current breast cancer diagnosis
* Active untreated major mental illness (e.g., schizophrenia, psychosis, bi-polar, substance abuse, panic disorder, PTSD diagnosis),
* Acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases such as Lupus, Rheumatoid Arthritis, Acute or Chronic Hepatitis, and Multiple Sclerosis, Graves' Disease, Chronic Fatigue Syndrome, Fibromyalgia etc.). example: history of heart disease, e.g., past stroke, myocardial infarction (MI), or congestive heart failure are not exclusionary.
* Significant cognitive impairment, \<32 on the Telephone Interview for Cognitive Status (TICS)
* Receipt of immunotherapy as part of treatment

Where it's running

• University of Miami
  Coral Gables, Florida, United States Recruiting

Study contacts

• Principal investigator: Michael Antoni, Ph.D — University of Miami
• Study coordinator: Dolores Perdomo, Ph.D
• Email: Dperdomo@miami.edu
• Phone: (305) 284-2220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.