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New treatment option for Breast Cancer
Official title Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)
ClinicalTrials.gov ID: NCT07502352
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- 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)
You likely can't join if
- 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...
- Significant cognitive impairment, \<32 on the Telephone Interview for Cognitive Status (TICS)
See the full eligibility 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
- 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...
- Significant cognitive impairment, \<32 on the Telephone Interview for Cognitive Status (TICS)
- Receipt of immunotherapy as part of treatment
The study team makes the final eligibility decision.
Where it's taking place
- Coral Gables, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coral Gables, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.