Cognitive Behavioral Stress Management for Breast Cancer

Overseen By Dolores Perdomo, Ph.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Adjuvant endocrine therapy

Must not be taking: Immunotherapy

Disqualifiers: Metastatic disease, Major mental illness, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Michael Antoni, Ph.D

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

Elevated distress (Impact of Event Scale-intrusive thoughts [IES-I] > 14 or elevated distress based on assessment of PI

I am currently receiving adjuvant endocrine therapy.

I may have had chemotherapy or radiation during my initial cancer treatment.

Exclusion Criteria

I have metastatic breast cancer that is either HER2 positive or triple negative.

Unable or unwilling to provide informed consent

Significant cognitive impairment, <32 on the Telephone Interview for Cognitive Status (TICS)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 weeks of group R-CBSM intervention via video calls

10 weeks

Weekly virtual group sessions

Follow-up

Participants are monitored for changes in quality of life, psychological adaptation, immune cell senescence, neuroendocrine regulation, and mental health

24 months

Assessments at baseline, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)

How Is the Trial Designed?

Group I: R-CBSM+Survivorship Care Planning (SCP) Experimental Treatment 2 Interventions

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.

Group II: Standard of Care Survivorship Care Planning (SCP Only) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+