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Emotions Immunology and Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03609671
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 2, 2018
Information provided by (Responsible Party):
Luz A. Venta, MD, The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Cancer Emotions Immunology Behavioral: Standard of Care + Experimental Individualized Therapy Other: Control: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to two groups.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Pilot Study: Emotions Immunology and Breast Cancer
Actual Study Start Date : November 23, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: Individualized Therapy

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.
Other: Control: Standard of Care
Participants will undergo standard of care only (no Intervention/no individualized therapy) .
Other Names:
  • No intervention
  • No Individualized Therapy

Primary Outcome Measures :
  1. Questionnaire#1, Adverse Childhood Experience (ACE). [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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.

  2. Questionnaire#2, Depression, Anxiety, and Stress Scale (DASS). [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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.

  3. Questionnaire#3, Experiences in Close Relationships-Revised (ECR-R). [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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.

  4. Questionnaire#4, Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4). [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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.

  5. Questionnaire#5, Benefit Finding Scale (BFS). [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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.

  6. Questionnaire#6, Acceptance and Action Questionnaire - II (AAQ-II) [ Time Frame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later). ]
    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 .

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03609671

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Contact: Luz A. Venta, MD 713-441-5097

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United States, Texas
Houston Methodist Hospital Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Cancer Center Research    713-441-0629   
Sub-Investigator: Jenny C Chang, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Luz A Venta, MD    713-441-5097   
Sponsors and Collaborators
Luz A. Venta, MD
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Principal Investigator: Luz A. Venta, MD The Methodist Hospital System

[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. [18.] Han, B., Enas, N. H. and McEntegart D. (2009). Randomization by minimization for unbalanced treatment allocation. Statistics in Medicine, 28(27), 3329-3346.

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Responsible Party: Luz A. Venta, MD, Principal Investigator, Houston Methodist Hospital Physician, The Methodist Hospital System Identifier: NCT03609671     History of Changes
Other Study ID Numbers: Pro00013603
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luz A. Venta, MD, The Methodist Hospital System:
Breast Cancer
Emotions Immunology

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases