Stress Management Therapy for Triple Negative Breast Cancer

Cleveland, OH

N/A

Recruiting

Led By Samilia Obeng-Gyasi, MD, MPH

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Untreated newly diagnosed triple negative breast cancer

Age >=18 years

Must not have

Individuals not able to speak and understand English

Male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a 10-wk stress reduction program can help patients with triple negative breast cancer reduce stress and address their health-related social needs.

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on stress management rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak or understand English.

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I am male.

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My breast cancer is at stage IV.

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I have a history of breast cancer or DCIS.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Biobehavioral Intervention

Participant Satisfaction with the Biobehavioral Intervention

Profile of Mood States for the Biobehavioral Intervention

Secondary study objectives

Biomarkers for allostatic load

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stress Management Therapy

2018

N/A

~30

Biospecimen Collection

2004

Completed Phase 3

~1810