Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients with Triple Negative Breast Cancer
- Conditions
- Anatomic Stage I Breast Cancer AJCC V8Hormone Receptor-Negative Breast CarcinomaTriple-Negative Breast CarcinomaAnatomic Stage II Breast Cancer AJCC V8Anatomic Stage III Breast Cancer AJCC V8HER2-Negative Breast Carcinoma
- Interventions
- Procedure: Biospecimen CollectionOther: Medical Chart ReviewProcedure: Stress Management TherapyOther: Survey Administration
- Registration Number
- NCT05677802
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- Age >=18 years
- Untreated newly diagnosed triple negative breast cancer
- Stages I-III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health Services Research (stress management therapy) Medical Chart Review 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. Health Services Research (stress management therapy) Biospecimen Collection 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. Health Services Research (stress management therapy) Stress Management Therapy 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. Health Services Research (stress management therapy) Survey Administration 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.
- Primary Outcome Measures
Name Time Method Participant Satisfaction with the Biobehavioral Intervention 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.
Profile of Mood States for the Biobehavioral Intervention 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.
Participant Biobehavioral Intervention 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 Outcome Measures
Name Time Method Biomarkers for allostatic load 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.
Trial Locations
- Locations (2)
MetroHealth
🇺🇸Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States