Clinical trial · Interventional
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| HER2-Negative Breast Carcinoma | HER2-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor-Negative Breast Carcinoma | Hormone Receptor-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Stress Management Therapy | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health Services Research (stress management therapy)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Medical Chart Review
- Procedure: Stress Management Therapy
- Other: Survey Administration
Primary outcomes (3)
- measure
- Participant Satisfaction with the Biobehavioral Intervention
- timeFrame
- Up to 2 years
- description
- 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.
- measure
- Profile of Mood States for the Biobehavioral Intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available