NCT07502352 Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)
| NCT ID | NCT07502352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-07 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2026-07 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study to find out if a program called Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) can help women with breast cancer in the period of survivorship after they have completed treatment. This is a group stress management program done from home using technology, like Zoom to conduct video calls to conduct group-based training in stress management techniques (e.g., relaxation, cognitive behavioral therapy, coping skills training) in a supportive environment. It is for women aged 50 or older who have finished their main breast cancer treatments (like surgery, radiation, or chemo) and are undergoing hormone treatment. This study is important because many breast cancer survivors still feel stress, even after treatment ends. Teaching stress management may help the body and mind work better and may slow down the effects of aging caused by cancer and stress.
Eligibility Criteria
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
Contact & Investigator
Michael Antoni, Ph.D
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07502352 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07502352 currently recruiting?
Yes, NCT07502352 is actively recruiting participants. Contact the research team at Dperdomo@miami.edu for enrollment information.
Where is the NCT07502352 trial being conducted?
This trial is being conducted at Coral Gables, United States.
Who is sponsoring the NCT07502352 clinical trial?
NCT07502352 is sponsored by University of Miami. The principal investigator is Michael Antoni, Ph.D at University of Miami. The trial plans to enroll 192 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.