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Recruiting NCT05677802

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

No phase Interventional Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Medical Chart Review, Stress Management Therapy, Survey Administration.
Who it may be relevant to
Registry conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo blood sample collection
  • Other Medical Chart Review
    Undergo medical cart review
  • Procedure Stress Management Therapy
    Receive biobehavioral stress reduction intervention
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Participant Satisfaction with the Biobehavioral Intervention [Time frame: Up to 2 years]
  • Profile of Mood States for the Biobehavioral Intervention [Time frame: Up to 2 years]
  • Participant Biobehavioral Intervention [Time frame: Up to 2 years]
Secondary outcome measures (1)
  • Biomarkers for allostatic load [Time frame: Up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • MetroHealth — Cleveland
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT05677802 · OSU-22083 · NCI-2022-08781

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗