Breast Cancer Clinical Trials

Find Breast Cancer Clinical Trials Near You

Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Miami
RECRUITING
Coral Gables
Contact Information
Primary
Dolores Perdomo, Ph.D
Dperdomo@miami.edu
(305) 284-2220
Backup
Dolores Perdomo
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2029-08
Participants
Target number of participants: 192
Treatments
Experimental: R-CBSM+Survivorship Care Planning (SCP)
Subjects in this group will receive 10 weeks of group R-CBSM intervention convened by a broadband connection for approximately 75 - 90 minutes at a mutually convenient time plus a standard of care survivorship care planning.
Active_comparator: Standard of Care Survivorship Care Planning (SCP Only)
Participants in this group will receive the standard of care survivorship care planning (SCP) only. Each participant will have a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have.
Related Therapeutic Areas
Sponsors
Leads: University of Miami
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov