Emotions Immunology and Breast Cancer

NCT03609671 | Completed

• 1 other identifier: Pro00013603
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Triple Negative Breast Cancer; Emotions; Immunology

Keywords

Breast Cancer; Emotions Immunology

Outcome Measures

Primary Outcomes (6)

• Questionnaire#1, Adverse Childhood Experience (ACE).

  The self-reported Adverse Childhood Experience Questionnaire measures different types of abuse, neglect, and other hallmarks of a challenging childhood. Scores range from 0-10, with 10 indicating highest childhood abuse \&/or neglect exposure with greater risk for negative consequences later in life, and 0 is lowest exposure and lower risk for negative consequences.questionnaires with immune responses. Pathologic tumor response is our measurable endpoint, focusing on immune cells in the tumor bed at lumpectomy or mastectomy.

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

• Questionnaire#2, Depression, Anxiety, and Stress Scale (DASS).

  The self-reported Depression, Anxiety, and Stress Scale Questionnaire is 3-part tool that measures motional states of depression, anxiety, and stress. Scores range from 0-42 for depression, 0-42 for anxiety and 0-42 for stress. A score closer to 42 for each state is indicative of extremely severe symptoms while a score closer to 0 indicates normal to mild symptom scores.

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

• Questionnaire#3, Experiences in Close Relationships-Revised (ECR-R).

  The self-reported Experiences in Close Relationships-Revised Adult Attachment Questionnaire is a tool that measures how an individual behaves in relationships with others. Scores range from 0-5. A score closer to 0 is indicative of attachment while a score closer to 5 indicates signs of attachment-avoidance.

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

• Questionnaire#4, Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4).

  The self-reported Functional Assessment of Cancer Therapy Questionnaire is a tool that measures how an individual behaves in relationships with others. Scored in a 5 point scale with a total score ranging from 0 to 164, with a higher score indicative of better health related quality of life.

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

• Questionnaire#5, Benefit Finding Scale (BFS).

  The self-reported Benefit Finding Questionnaire is a tool that measures how an individual might feel their cancer diagnosis contributes to their outlook on life. Scored in a 5 point scale with total scores ranging from 17-85. Higher scores indicate more benefit derived from breast cancer.

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

• Questionnaire#6, Acceptance and Action Questionnaire - II (AAQ-II)

  The self-reported Acceptance and Action Questionnaire - II is a tool that measures psychological inflexibility and experiential avoidance. Score in a 7 point scale, range 7 to 49. A higher score indicates greater levels of psychological inflexibility .

  Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

Study Arms (2)

Standard of Care + Intervention (Individualized Therapy)

EXPERIMENTAL

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.

Behavioral: Standard of Care + Experimental Individualized Therapy

Control Group: Standard of Care

OTHER

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.

Other: Control: Standard of Care

Interventions

Standard of Care + Experimental Individualized Therapy BEHAVIORAL

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

Also known as: Individualized Therapy

Standard of Care + Intervention (Individualized Therapy)

Control: Standard of Care OTHER

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

Also known as: No intervention, No Individualized Therapy

Control Group: Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or planned to become pregnant
• Patient not fluent in English
• Patients undergoing individual psychotherapy

Sponsors & Collaborators

• Luz A. Venta, MD: lead

Study Sites (2)

Houston Methodist Hospital Cancer Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• [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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Luz A. Venta, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Houston Methodist Hospital Physician

Model Details: Patients will be randomized to two groups.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: November 23, 2015
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (2)