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Stress Management Therapy for Triple Negative Breast Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.

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.

Select...

I am 18 years old or older.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the biobehavioral intervention

Feasibility biobehavioral intervention

Tolerability of the biobehavioral intervention

Secondary outcome measures

Completeness of biomarkers collected to calculate allostatic load

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

Biospecimen Collection

2004

Completed Phase 2

~1700

Stress Management Therapy

2018

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

321 Previous Clinical Trials

290,095 Total Patients Enrolled

22 Trials studying Breast Cancer

2,884 Patients Enrolled for Breast Cancer

Samilia Obeng-Gyasi, MD, MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Biobehavioral Stress Reduction Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05677802 — N/A

Breast Cancer Research Study Groups: Health Services Research (stress management therapy)

Breast Cancer Clinical Trial 2023: Biobehavioral Stress Reduction Intervention Highlights & Side Effects. Trial Name: NCT05677802 — N/A

Biobehavioral Stress Reduction Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05677802 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for prospective participants to join this clinical trial?

"As indicated on clinicaltrials.gov, this trial is presently recruiting volunteers who meet the criteria for participation. The medical study was first announced on December 14th 2022 and underwent its most recent update a fortnight later."

Answered by AI

What is the peak patient participation rate of this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this research is still recruiting participants and was first listed on December 14th 2022, as per the most recent update of December 28th 2022. Forty people are being sought from a single site to take part in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer

Samilia Obeng-Gyasi 2022. "Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05677802.