192 Participants NeededMy employer runs this trial

Cognitive Behavioral Stress Management for Breast Cancer

DP
DP
Overseen ByDolores Perdomo
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Miami
Must be taking: Adjuvant endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) can reduce stress in women who have completed their primary breast cancer treatments. The program teaches stress management techniques, such as relaxation and coping skills, from home using technology like Zoom. It targets women aged 50 or older who have finished treatments like surgery or chemotherapy and are currently on hormone therapy. Participants will receive either the R-CBSM program with additional survivorship care planning or standard care planning alone. The trial seeks to improve mental health and potentially slow aging effects from cancer and stress. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-treatment care for breast cancer survivors.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that if you are on anti-depressants or anxiety medications, you should have been on a stable regimen for more than 2 months. You will continue your hormone treatment during the trial.

What prior data suggests that this stress management program is safe for breast cancer survivors?

Research has shown that cognitive behavioral stress management (CBSM) is generally safe for breast cancer patients. Studies have found that this method helps people relax and feel less stressed without causing major side effects. When offered remotely, as in the R-CBSM program, it has been well-received. Participants reported feeling more relaxed and positive, with no major safety issues. This suggests that the stress management techniques used in R-CBSM are safe for those who have completed their main cancer treatments and are managing stress at home.12345

Why are researchers excited about this trial?

Researchers are excited about the Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) for breast cancer patients because it offers a unique approach to managing stress remotely, which is not typical in standard care options like medication or in-person therapy. Unlike traditional treatments that require face-to-face sessions, R-CBSM can be accessed from the comfort of a patient's home via a broadband connection. This convenience enhances accessibility, allowing patients to fit stress management into their schedules more easily. Additionally, combining R-CBSM with Survivorship Care Planning provides a comprehensive approach to improving mental well-being during recovery.

What evidence suggests that Remotely-delivered Cognitive Behavioral Stress Management is effective for stress management in breast cancer survivors?

Studies have shown that cognitive-behavioral stress management (CBSM) can help women with breast cancer manage stress and improve overall well-being. Research indicates that CBSM reduces distress and helps patients find more positive outcomes during and after breast cancer treatment. In this trial, one group of participants will receive a Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) combined with Survivorship Care Planning (SCP). Early findings suggest that CBSM can promote relaxation and enhance mood, which is important for long-term health. This method may help the body and mind work better together, potentially slowing the aging effects caused by cancer and stress.34567

Who Is on the Research Team?

MA

Michael Antoni, Ph.D

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women aged 50 or older who have finished main treatment (surgery, chemo, or radiation) for certain types of early-stage breast cancer and are now on hormone therapy. Participants must feel ongoing stress, be post-menopausal, speak English or Spanish, and not have advanced cancer or serious mental/immune conditions.

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.
See 6 more

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)
See 4 more

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)

Trial Overview

The study compares usual follow-up care with a group-based stress management program done remotely using video calls. The program teaches relaxation and coping skills to help manage stress in breast cancer survivors after treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: R-CBSM+Survivorship Care Planning (SCP)Experimental Treatment2 Interventions
Group II: Standard of Care Survivorship Care Planning (SCP Only)Active Control1 Intervention

Find a Clinic Near You

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+

Citations

Remotely-Delivered Cognitive Behavioral Stress ...

This is a group stress management program done from home using technology, like Zoom to conduct video calls to conduct group-based training in ...

A randomized controlled trial of cognitive-behavioral stress ...

Cognitive-behavioral stress management (CBSM) improves psychological adaptation and lowers distress during breast cancer treatment and long-term follow-ups. We ...

The Effects of Cognitive-Behavioral Stress Management for...

Cognitive-behavioral stress management can help breast cancer patients develop skills to increase relaxation, benefit finding, and positive affect.

Project Details

This is the first randomized controlled trial to test the effects of a R-CBSM intervention on CAA and health outcomes in older, distressed HR+ Her2neu BCS over ...

Remotely-Delivered Cognitive Behavioral Stress Management ...

This study is important because many breast cancer survivors still feel stress, even after treatment ends. Teaching stress management may help ...

Cognitive Behavioral Stress Management Effects on Cancer ...

A diagnosis of breast cancer is often accompanied by significant psychological distress [6], which may lead to downstream physiological ...

Cognitive behavioral digital therapeutic effects on distress and ...

Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial. Publication Date.