Clinical trial · Interventional
Emotions Immunology and Breast Cancer
A Pilot Study: Emotions Immunology and Breast Cancer
NCT03609671CI-TRIAL-00040268completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Pilot study representing a proof of concept regarding the potential for immune system enhancement with psychotherapy, resulting in improved immunological response at lumpectomy or mastectomy in patients undergoing neoadjuvant chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Emotions | — | UNRESOLVED | — |
| Immunology | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control: Standard of Care | Other | — | UNRESOLVED |
| Standard of Care + Experimental Individualized Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard of Care + Intervention (Individualized Therapy)
- description
- Intervention (individualized therapy) plus Standard of Care, and the completion of a psychological questionnaire at chemotherapy start and at the end, approximately four to six months later.
- interventionNames
- Behavioral: Standard of Care + Experimental Individualized Therapy
- type
- OTHER
- label
- Control Group: Standard of Care
- description
- Standard of Care plus the completion of a psychological questionnaire at the beginning of the chemotherapy and at the end, approximately four to six months later.
- interventionNames
- Other: Control: Standard of Care
Primary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-pregnant adult (eighteen years old or older) women with a diagnosis of breast cancer * Planned to receive neoadjuvant chemotherapy for about six month duration * Must be fluent in speaking, reading and writing English * Not planning on undergoing individual psychotherapy during the study time outside the study. * Biopsy procedure to be performed with surgical treatment planned at Houston Methodist System Exclusion Criteria: * Pregnant or planned to become pregnant * Patient not fluent in English * Patients undergoing individual psychotherapy
References
Publications (1)
- BACKGROUND[1.] Baumeister, D., et al. Childhood trauma and adult inflammation: a meta-analysis of peripheral C-reactive protein, interleukin-6 and tumor necrosis factor-α. Molecular Psychiatry: 2015: 1-8. [2.] Bleiker, E.M. et al. Personality factors and breast cancer development: a prospective longitudinal study. Journal of the National Cancer Institute; 1996: 1478-1482. [3.] Brod, S., et al. 'As above, so below." Examining the interplay between emotion and the immune system. Immunology, 2014: 143, 311-318. [4.] Buchheim A, Viviani R, Taubner S, et al. EPA-0142 - Neural changes in depressed patients during psychodynamic psychotherapy: An fMRI Study. European Psychiatry [serial online]. January 1, 2014;29(1, Number 1 Supplement 1):1. [5.] Carrig M, Kolden G, Strauman T. Using functional magnetic resonance imaging in psychotherapy research: A brief introduction to concepts, methods and task selection. Quantitative and qualitative methods in psychotherapy research [e-book]. New York, NY, US: Routledge/Taylor & Francis Group; 2014:72-84. [6.] Dumas J, Makarewicz J, Newhouse P, et al. Chemotherapy altered brain functional connectivity in women with breast cancer: a pilot study. Brain Imaging And Behavior [serial online]. December 1, 2013;7(4):524-532. [7.] Spiegel, D. Minding the body: Psychotherapy and cancer survival. British Journal of Health Psychology, 2014, 19: 465-485. [8.] Temoshok L. Personality, coping style, emotion and cancer: towards an integrative model. Cancer Surv 1987:6:545-67. [9.] Wirsching, M., et al., Psychological identification of breast cancer patients before biopsy. Journal of Psychosomatic Research, 1982: 26(1): 1-10. [10.] Zonderman AB, et al. Depression as a risk for cancer morbidity and mortality in a nationally representative sample. JAMA 1989;262:1191-5. [11.] Persky VW, et al. Personality and risk of cancer: 20-year follow-up of the Western Electric Study. Psychosom Med 1987;49:435-49. [12.] Chida, Y., Hamer, M., Wardle, J., & Steptoe, A. (2008). Do stress-related psychosocial factors contribute to cancer incidence and survival?. Nature Clinical Practice. Oncology, 5(8), 466-475. doi:10.1038/ncponc1134 [13.] Fagundes, C. P., Lindgren, M. E., & Kiecolt-Glaser, J. K. (2013). Psychoneuroimmunology and Cancer: Incidence, Progression, and Quality of Life. In Psychological Aspects of Cancer (pp. 1-11). Springer US. [14.] Lillberg, K., Verkasalo, P. K., Kaprio, J., Teppo, L., Helenius, H., & Koskenvuo, M. (2003). Stressful life events and risk of breast cancer in 10,808 women: a cohort study. American Journal Of Epidemiology, 157(5), 415-423. [15.] Lutgendorf, S. K., Johnsen, E. L., Cooper, B., Anderson, B., Sorosky, J. I., Buller, R.E., & Sood, A. K. (2002). Vascular endothelial growth factor and social support in patients with ovarian carcinoma. Cancer, 95(4), 808-815. [16.] Lutgendorf, S. K., Lamkin, D. M., Jennings, N. B., Arevalo, J. G., Penedo, F., DeGeest, K., & ... Sood, A. K. (2008). Biobehavioral influences on matrix metalloproteinase expression in ovarian carcinoma. Clinical Cancer Research: An Official Journal Of The American Association For Cancer Research, 14(21), 6839 6846. doi:10.1158/1078-0432.CCR-08-0230 [17.] Pocock, S.J., & Simon, R. (1975). Sequential Treatment Assigment with Balancing for Prognostic Factors in the Controlled Clinical Trial, Biometrics, 31(1), 103-115. doi.org/10.2307%2F2529712 [18.] Han, B., Enas, N. H. and McEntegart D. (2009). Randomization by minimization for unbalanced treatment allocation. Statistics in Medicine, 28(27), 3329-3346.