Emotions Immunology and Breast Cancer

NCT ID: NCT03609671

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-23
• Study Completion Date: 2019-03-18

Brief Summary

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.

Detailed Description

Study participants will receive be randomized to the experimental group (receive individualized psychotherapy + standard of care) or the control group (standard of care) and both groups will complete psychological questionnaires. Both groups will have blood sampling and have their biopsied tissue read for immunological factors.

Patients with triple negative breast cancer or with breast cancers presenting at a large size (greater than one centimeter) have a worst prognosis than other types of breast cancer or cancers that are diagnosed when smaller than one centimeter. For these patients, neoadjuvant chemotherapy, that is chemotherapy given before surgical removal of the cancer, is often used. Common indications for using neoadjuvant therapy include: available clinical trial, learning about the tumor response in vivo to a particular chemotherapy and shrinking the tumor so as to convert a mastectomy to a lumpectomy at the time of resection. In patients receiving neoadjuvant treatment, there is usually 6-months between the diagnosis and the surgical breast tumor resection during which the chemotherapy is administered, and during that time patients are offered support group therapy. Although the prognosis for breast cancer patients has improved, this subset of patients still poses a clinical challenge.

Growing evidence in the psychological field has documented a link between the immune system and psychological factors, emphasizing that stress and trauma are detrimental to the ability and effectiveness of the immune system and emphasizing that mental health has an importance not only in and of itself on how the person feels, but also translates into physical health at least in part through the immune system. Personality traits and other emotional factors remain as viable candidates contributing to the development of malignancies, but the research in this area is confusing. For example, many authors report that depressed women are more prone to develop breast cancer than others, while other research has failed to find such a connection.

Nevertheless, many clinicians notice that cancer tends to present after a major loss or emotional trauma. Some research suggests that the suppression of negative emotions or difficulty expressing emotions such as anger and hostility are characteristic of the cancer-prone personality, so that in a typical study, clinicians who interviewed patients prior to breast biopsy were able to predict the presence of a malignancy in 94% of cases based on psychological factors alone. Similarly, a study has been able to predict with 75% accuracy those patients who had early cancer with no knowledge of their Pap smear results, based on the presence of extreme hopelessness. However, although there are many similar studies, other researchers have not been able to confirm the importance of emotional factors.

Conditions

Breast Cancer; Triple Negative Breast Cancer; Emotions; Immunology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of Care + Intervention (Individualized Therapy)

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.

Group Type: EXPERIMENTAL

Standard of Care + Experimental Individualized Therapy

Intervention Type: BEHAVIORAL

Participants will receive standard of care plus supportive psychotherapy for a one hour, weekly, during the time they are undergoing neoadjuvant treatments.

Control Group: Standard of Care

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.

Group Type: OTHER

Control: Standard of Care

Intervention Type: OTHER

Participants will undergo standard of care only (no Intervention/no individualized therapy) .

Interventions

Standard of Care + Experimental Individualized Therapy

Participants will receive standard of care plus supportive psychotherapy for a one hour, weekly, during the time they are undergoing neoadjuvant treatments.

Intervention Type: BEHAVIORAL

Control: Standard of Care

Participants will undergo standard of care only (no Intervention/no individualized therapy) .

Intervention Type: OTHER

Other Intervention Names

Individualized Therapy; No intervention; No Individualized Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Luz A. Venta, MD

OTHER

Sponsor Role: lead

Responsible Party

Luz A. Venta, MD

Principal Investigator, Houston Methodist Hospital Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luz A. Venta, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital Cancer Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

References

[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.

Reference Type: BACKGROUND

Other Identifiers

Pro00013603

Identifier Type: -

Identifier Source: org_study_id