Stress Management Therapy for Triple Negative Breast Cancer

Recruiting at 1 trial location

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Male, Stage IV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a stress management program, specifically a Biobehavioral Stress Reduction Intervention, can assist individuals with newly diagnosed triple negative breast cancer. Participants will engage in stress reduction activities, such as relaxation techniques, and receive support for health-related needs like transportation. The trial aims to assess the impact of these approaches on stress levels, using both patient feedback and biological markers. It seeks participants with stages I-III triple negative breast cancer who have not yet begun treatment.

As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance stress management for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this stress management therapy is safe for patients with triple negative breast cancer?

Research has shown that stress management programs are generally safe for people with breast cancer. Studies have used these programs with breast cancer patients without causing harm. For example, Cognitive-Behavioral Stress Management (CBSM) has helped without serious side effects.

In one study, women with breast cancer used these stress management techniques and experienced positive results, reporting no major problems from the treatment. Another study found that stress reduction programs could lower anxiety in breast cancer survivors without causing new health issues.

Overall, these programs seem well-tolerated, usually not causing unpleasant side effects. While a detailed description of this specific stress reduction treatment is not provided, the safety data from similar programs is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the biobehavioral stress reduction intervention for triple-negative breast cancer because it offers a novel approach to managing stress, which is often overlooked in cancer care. Unlike traditional treatments that focus solely on the cancer itself, this therapy emphasizes the mind-body connection, aiming to reduce stress through behavioral techniques. This could potentially improve patients' overall well-being and complement existing cancer treatments by addressing the psychological aspects of the condition. The intervention's focus on stress management is unique and could pave the way for more holistic cancer care strategies.

What evidence suggests that this stress management therapy is effective for triple negative breast cancer?

Research shows that managing stress can help breast cancer patients. Studies have found that techniques like relaxation exercises make patients feel calmer and more positive. One study discovered that these techniques reduce certain stress indicators in the body, potentially improving overall health. Psychological support has also improved quality of life by lowering stress levels. This trial will evaluate a biobehavioral stress reduction intervention, which participants will receive as part of the study. These findings suggest that stress management programs could help people with triple negative breast cancer cope better with their condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Samilia Obeng-Gyasi, MD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed, untreated triple negative breast cancer at stages I-III. It's not open to prisoners, men, certain ethnic groups, those who can't speak and understand English, or anyone with stage IV breast cancer or a history of DCIS or invasive breast cancer.

Inclusion Criteria

I have been diagnosed with triple negative breast cancer and have not received any treatment.

My cancer is at an early to mid-stage (I-III).

Exclusion Criteria

I cannot speak or understand English.

I am male.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a biobehavioral stress reduction intervention over ten weeks, including stress reduction techniques, coping, problem solving, communication, and social support.

10 weeks

Weekly sessions

Follow-up

Participants undergo blood specimen collection and medical record review to assess stress and biomarkers.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Biobehavioral Stress Reduction Intervention

Trial Overview

The study tests a ten-week biobehavioral stress reduction program that includes relaxation techniques, coping strategies, problem-solving skills enhancement and social support for patients with triple negative breast cancer. It also assesses the participants' health-related social needs.

How Is the Trial Designed?

Group I: Health Services Research (stress management therapy) Experimental Treatment 4 Interventions

Patients receive biobehavioral stress reduction intervention while on study. Patients undergo blood specimen collection at baseline and follow up and have their medical records reviewed.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study of 22,812 women with triple negative breast cancer (TNBC), marital status significantly influenced breast cancer-specific mortality, particularly among white and Asian/Pacific Islander women, with separated and widowed white women showing a higher risk of mortality compared to married women.

The findings suggest that marital status does not affect mortality risk for black or Hispanic women with TNBC, indicating that the protective effect of marriage may vary by race/ethnicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of marital status and race/ethnicity on risk of mortality for triple negative breast cancer. Parise, C., Caggiano, V.[2018]

Triple-negative breast cancer (TNBC) was found to be more aggressive, with a 5-year overall survival rate of 62.1% compared to 80.8% for non-TNBC, indicating a significant difference in prognosis between the two types.

Factors such as multicentricity and lymph node involvement were linked to worse outcomes in TNBC, while in non-TNBC, poorer prognosis was associated with nonwhite ethnicity, lower education levels, and advanced cancer stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival Study of Triple-Negative and Non-Triple-Negative Breast Cancer in a Brazilian Cohort. Gonçalves, H., Guerra, MR., Duarte Cintra, JR., et al.[2022]

This study is the first to explore the psychosocial experiences of women with triple negative breast cancer (TNBC), highlighting their unique challenges and unmet needs, particularly among younger women and women of color.

Participants reported feeling intense uncertainty and insecurity regarding their diagnosis and treatment decisions, indicating a strong need for tailored support and resources for managing their specific experiences with TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"An addendum to breast cancer": the triple negative experience. Turkman, YE., Kennedy, HP., Harris, LN., et al.[2018]

In a study of 197 women with triple-negative breast cancer (TNBC), factors such as body mass index (BMI), smoking, alcohol consumption, physical activity, and parity did not significantly affect overall survival (OS) or disease-free survival (DFS) during a median follow-up of 41.43 months.

Despite 40.38% of patients on neo-adjuvant chemotherapy achieving complete remission, the study found that lifestyle factors and demographics had no measurable impact on the disease course for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of body mass index, smoking habit, alcohol consumption, physical activity and parity on disease course of women with triple-negative breast cancer. Schmidt, G., Schneider, C., Gerlinger, C., et al.[2021]

In a study of 235 women with triple negative breast cancer undergoing neoadjuvant chemotherapy, advanced clinical stage (III) was linked to a lower rate of pathological complete response (pCR) and worse survival outcomes.

Alcohol consumption negatively impacted event-free survival (EFS) and overall survival (OS), while achieving pCR was associated with significantly better EFS and OS, highlighting the importance of treatment response in improving survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sociodemographic, Clinical, and Pathological Factors Influencing Outcomes in Locally Advanced Triple Negative Breast Cancer: A Brazilian Cohort. da Silva, JL., de Paula, BHR., Small, IA., et al.[2022]

African American women with non-triple-negative breast cancer (non-TNBC) experienced more intense symptoms like pain and nausea during chemotherapy, but reported better emotional functioning and used more positive coping strategies compared to those with triple-negative breast cancer (TNBC).

Both groups of women showed a need for improved coping skills and psychological support, suggesting that a comprehensive psychological care program could help reduce psychological distress and enhance coping abilities during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in Coping Among African American Women With Breast Cancer and Triple-Negative Breast Cancer. Watkins, CC., Kamara Kanu, I., Hamilton, JB., et al.[2022]

A study of 121 Chinese patients with triple negative breast cancer found that higher levels of hope, self-efficacy, and social support are strongly associated with better quality of life, indicating these factors are crucial for patient well-being.

Multiple regression analysis revealed that hope, income, self-efficacy, and social support positively influence quality of life, while cancer stage negatively impacts it, suggesting that interventions to enhance these positive factors could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among breast cancer survivors with triple negative breast cancer--role of hope, self-efficacy and social support. Shen, A., Qiang, W., Wang, Y., et al.[2020]

The Responses to Stress Questionnaire-cancer version (RSQ-CV) was developed and validated with 232 women diagnosed with breast cancer, identifying three voluntary coping strategies and two involuntary stress responses.

The RSQ-CV demonstrated strong reliability and validity, showing significant correlations with anxiety and depression symptoms, making it a useful tool for understanding how breast cancer patients cope with stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of coping and stress responses in women with breast cancer. Compas, BE., Beckjord, E., Agocha, B., et al.[2015]

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