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

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 improve health and wellbeing in a general population of patients with a history of breast cancer. The study will also get feedback (e.g., implementation barriers and facilitators) from relevant stakeholders.

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.

Is the stress management treatment safe for breast cancer survivors?

The studies on stress management interventions for breast cancer survivors, like Nuevo Amanecer and digital apps, focus on improving psychological well-being and quality of life, suggesting they are generally safe for use in humans. ^{1 2 3 4 5}

How is the VSMART treatment different from other stress management treatments for breast cancer survivors?

VSMART is unique because it uses video conferencing to deliver stress management and relaxation training, making it accessible for breast cancer survivors who may have difficulty attending in-person sessions. This approach allows for real-time interaction and support, which can be more engaging and personalized compared to other online or workbook-based interventions. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Video-Conferenced Stress Management and Relaxation Training (VSMART) for breast cancer survivors?

Research shows that video-based stress management and relaxation programs can help reduce depression, anxiety, and uncertainty in breast cancer patients, suggesting that VSMART might also be effective. ^{1 3 8 9 10}

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

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of pretreatment video-based psychoeducation for patients with breast cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Translating a stress management intervention for rural Latina breast cancer survivors: The Nuevo Amanecer-II. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Digital stress management in cancer: Testing StressProffen in a 12-month randomized controlled trial. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral- and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer: Development Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. [2022]

10. United States 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. [2022]