Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05677802

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth, Cleveland, Ohio, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire (CSQ). CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction (e.g., quality of service, the degree to which needs were met, overall satisfaction).

III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States.

III Feasibility of the biobehavioral intervention will be assessed using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each BBI session; and, 3) number/percent of patients retained and completing 10 BBI sessions.

SECONDARY OBJECTIVE:

I. To examine the feasibility of collecting biomarkers--white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI).

EXPLORATORY OBJECTIVE:

I. To test for pre/post effects of the biobehavioral stress reduction intervention on measures of stress (Impact of Events Scale), mood and psychological symptoms, and allostatic load.

OUTLINE:

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >=18 years
  • Untreated newly diagnosed triple negative breast cancer
  • Stages I-III

Exclusion criteria

  • Prisoners
  • Male
  • Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander
  • Individuals not able to speak and understand English
  • Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer
  • Stage IV breast cancer

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

medical chart review

Other

Undergo medical cart review

Other names: Chart Review

Stress Management Therapy

Procedure

Receive biobehavioral stress reduction intervention

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Participant Satisfaction with the Biobehavioral Intervention

    Time frame: Up to 2 years

    Acceptability will be measured at the end of the intervention using the Client Satisfaction Questionnaire (CSQ). CSQ scores range from 8-32 with higher scores indicating higher satisfaction.

  2. Profile of Mood States for the Biobehavioral Intervention

    Time frame: Up to 2 years

    This will be assessed analyzing pre to post treatment change on the Profile of Mood States short form. The Profile of Mood States short from is a 37 item survey with lower scores indicative of stable mood.

  3. Participant Biobehavioral Intervention

    Time frame: Up to 2 years

    Feasibility will be evaluated using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each Biobehavioral intervention (BBI) session; and, 3) number/percent of patients retained and completing 10 BBI sessions.

Secondary outcomes

  1. Biomarkers for allostatic load

    Time frame: Up to 2 years

    The points for each biomarker will be summarized into a total score ranging from 0-12. The pre-test allostatic load biomarker will be based on the distribution of each biomarker within the study sample at diagnosis. For each biomarker, each patient will be stratified into quartiles. A point will be assigned for membership in the worst quartile. The post-test allostatic load will be calculated similar to the pre-test allostatic load using biomarkers collected after the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.