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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast CarcinomaHormone Receptor-Negative Breast CarcinomaTriple-Negative Breast Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University Comprehensive Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >=18 years

Untreated newly diagnosed triple negative breast cancer

Stages I-III

Disqualifiers

Prisoners

Male

Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander

Individuals not able to speak and understand English

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Medical Chart Review

    Other intervention

    Undergo medical cart review

  • Stress Management Therapy

    Procedure/Surgery

    Receive biobehavioral stress reduction intervention

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Health Services Research (stress management therapy)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Participant Satisfaction with the Biobehavioral Intervention

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.

Time frame
Up to 2 years
2

Profile of Mood States for the Biobehavioral Intervention

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.

Time frame
Up to 2 years
3

Participant Biobehavioral Intervention

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.

Time frame
Up to 2 years

Secondary outcomes

1

Biomarkers for allostatic load

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.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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