Stress Management for Breast Cancer Survivors

(VSMART Trial)

Overseen By Sydney McGlawn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-Alabama resident, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stress management program designed specifically for breast cancer survivors in Alabama. The goal is to determine if this program, which includes video-conferenced relaxation training (VSMART), can improve health and well-being. The study will also collect feedback on the ease or difficulty of implementing the program. Breast cancer survivors living in Alabama neighborhoods with many challenges may be a good fit. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance support for breast cancer survivors.

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

The trial information does not specify whether you need to stop taking your current medications.

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

Studies have shown that video-based stress management and relaxation programs, such as VSMART, are safe for breast cancer patients. Research indicates these programs can help reduce feelings of depression, anxiety, and uncertainty. No major side effects have been reported from using VSMART, suggesting it is well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for managing stress in breast cancer survivors, which often includes in-person therapy sessions or support groups, VSMART offers a unique approach by delivering stress management and relaxation training via video conferencing. This method makes it highly accessible to survivors who may have mobility issues or live far from treatment centers. Researchers are excited because VSMART could provide a more flexible and convenient way to support mental health, potentially increasing adherence and improving quality of life for breast cancer survivors.

What evidence suggests that this stress management program is effective for breast cancer survivors?

Research shows that stress management programs like VSMART, which participants in this trial will receive, can help breast cancer survivors. Studies have found that online programs, such as VSMART, reduce feelings of depression and stress. These programs use video calls to provide talk therapy and relaxation exercises. Participants have reported better mental health and overall well-being. This suggests that VSMART could be a good option for managing stress in breast cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Chloe Taub, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors in Alabama. It's designed to see if a stress management program, delivered through video calls, can help improve their health and wellbeing. Participants will also provide feedback on the program.

Inclusion Criteria

Currently living in Alabama

Living in neighborhood with high deprivation index

I have survived breast cancer.

Exclusion Criteria

Non-Alabama resident

Living in neighborhood with low deprivation index

I have never had breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a video-conferenced stress management and relaxation training program

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for feedback on feasibility and acceptability of the program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Video-Conferenced Stress Management and Relaxation Training (VSMART)

Trial Overview The VSMART program is being tested for its effectiveness in managing stress among breast cancer survivors. The study involves regular sessions via video conferencing aimed at teaching relaxation techniques and coping strategies.

How Is the Trial Designed?

Group I: Breast cancer survivors receiving stress management program Experimental Treatment 1 Intervention

Breast cancer survivors receiving stress management program

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Mindful awareness practices (MAPs) significantly reduced intrusive thoughts and worry in younger breast cancer survivors, and increased positive affect and a sense of meaning in life, with effects lasting up to 3 months after the intervention.

Compared to a wait-list control group, MAPs also showed a decrease in proinflammatory gene expression, suggesting potential immune benefits, while survivorship education (SE) also improved psychological outcomes but did not affect inflammation as significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. Bower, JE., Partridge, AH., Wolff, AC., et al.[2023]

Pretreatment video-based psychoeducation significantly reduced levels of depression, anxiety, and uncertainty in breast cancer patients, with moderate effect sizes observed for depression (-0.57) and small for anxiety (-0.25) at 3 months post-intervention.

In contrast, the control group experienced an increase in depression scores at 3 months, highlighting the potential benefits of early psychoeducational interventions for managing mental health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of pretreatment video-based psychoeducation for patients with breast cancer. Sato, T., Seto, M., Sangai, T., et al.[2023]

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.

Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06924788

Video-Conferenced Stress Management and Relaxation ... In a sample of Alabama breast cancer survivors, the proposed study tests the feasibility and acceptability of a stress management program that has been shown to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03955991

VSMART (Video-Conference Stress Management and ... The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and ...

3. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/clinical-trials/trials/vsmart-videoconference-stress-management-and-relaxation-training-for-older-women-with-breast-cancer-20160525

VSMART (Video-Conference Stress Management and ... Video-conference stress management and relaxation training for older women with breast cancer. Principal Investigator: Michael Antoni.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409339/

Telehealth Approach in Breast Cancer Care: A Systematic ... Based on a recent meta-analysis, telehealth-based interventions are effective in reducing psychological symptoms such as depression and stress ...

5. annualreviews.org annualreviews.org/content/journals/10.1146/annurev-psych-030122-124119

Stress Management Interventions to Facilitate ... Stress management interventions to facilitate psychological and physiological adaptation and optimal health outcomes in cancer patients and survivors.

6. withpower.com withpower.com/trial/phase-breast-cancer-early-stage-breast-cancer-stage-1-3-4-2025-bd5f9

Stress Management for Breast Cancer Survivors (VSMART Trial) Research shows that video-based stress management and relaxation programs can help reduce depression, anxiety, and uncertainty in breast cancer patients, ...

7. elsevier.es elsevier.es/en-revista-international-journal-clinical-health-psychology-355-pdf-download-S1697260025000729

International Journal of Clinical and Health Psychology Video- conferenced stress management and relaxation training (VSMART) improves psychological adaptation and influenza vaccine response in ...