40 Participants Needed

Stress Management Therapy for Triple Negative Breast Cancer

Recruiting at 1 trial location
TO
Overseen ByThe Ohio State Comprehensive Cancer Center
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Biobehavioral Stress Reduction Intervention for Triple Negative Breast Cancer?

While there is no direct evidence from the provided research articles about the effectiveness of Biobehavioral Stress Reduction Intervention specifically for Triple Negative Breast Cancer, studies highlight the importance of coping strategies and social support in improving the quality of life for breast cancer patients. These elements are often part of stress management therapies, suggesting potential benefits for patients undergoing such treatments.12345

How is the Biobehavioral Stress Reduction Intervention treatment different for triple-negative breast cancer?

The Biobehavioral Stress Reduction Intervention is unique because it focuses on managing stress and psychological well-being, which is important for triple-negative breast cancer patients who have limited treatment options and face high stress levels. Unlike traditional treatments that target the cancer directly, this therapy aims to improve patients' coping abilities and reduce psychological distress.23678

What is the purpose of this trial?

This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.

Research Team

SO

Samilia Obeng-Gyasi, MD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Health Services Research (stress management therapy)Experimental Treatment4 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Findings from Research

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

References

Quality of life among breast cancer survivors with triple negative breast cancer--role of hope, self-efficacy and social support. [2020]
"An addendum to breast cancer": the triple negative experience. [2018]
Differences in Coping Among African American Women With Breast Cancer and Triple-Negative Breast Cancer. [2022]
Sociodemographic, Clinical, and Pathological Factors Influencing Outcomes in Locally Advanced Triple Negative Breast Cancer: A Brazilian Cohort. [2022]
Measurement of coping and stress responses in women with breast cancer. [2015]
The influence of marital status and race/ethnicity on risk of mortality for triple negative breast cancer. [2018]
Survival Study of Triple-Negative and Non-Triple-Negative Breast Cancer in a Brazilian Cohort. [2022]
Impact of body mass index, smoking habit, alcohol consumption, physical activity and parity on disease course of women with triple-negative breast cancer. [2021]
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