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Emotions Immunology and Breast Cancer

Primary Purpose

Breast Cancer, Triple Negative Breast Cancer, Emotions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care + Experimental Individualized Therapy
Control: Standard of Care
Sponsored by
Luz A. Venta, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Emotions Immunology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Houston Methodist Hospital Cancer Center
  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard of Care + Intervention (Individualized Therapy)

Control Group: Standard of Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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 .

Secondary Outcome Measures

Full Information

First Posted
July 24, 2018
Last Updated
August 26, 2019
Sponsor
Luz A. Venta, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03609671
Brief Title
Emotions Immunology and Breast Cancer
Official Title
A Pilot Study: Emotions Immunology and Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luz A. Venta, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Triple Negative Breast Cancer, Emotions, Immunology
Keywords
Breast Cancer, Emotions Immunology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to two groups.
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care + Intervention (Individualized Therapy)
Arm Type
Experimental
Arm 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.
Arm Title
Control Group: Standard of Care
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care + Experimental Individualized Therapy
Other Intervention Name(s)
Individualized Therapy
Intervention Description
Participants will receive standard of care plus supportive psychotherapy for a one hour, weekly, during the time they are undergoing neoadjuvant treatments.
Intervention Type
Other
Intervention Name(s)
Control: Standard of Care
Other Intervention Name(s)
No intervention, No Individualized Therapy
Intervention Description
Participants will undergo standard of care only (no Intervention/no individualized therapy) .
Primary Outcome Measure Information:
Title
Questionnaire#1, Adverse Childhood Experience (ACE).
Description
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.
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Title
Questionnaire#2, Depression, Anxiety, and Stress Scale (DASS).
Description
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.
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Title
Questionnaire#3, Experiences in Close Relationships-Revised (ECR-R).
Description
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.
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Title
Questionnaire#4, Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4).
Description
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.
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Title
Questionnaire#5, Benefit Finding Scale (BFS).
Description
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.
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Title
Questionnaire#6, Acceptance and Action Questionnaire - II (AAQ-II)
Description
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 .
Time Frame
Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luz A. Venta, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
to be determined
Citations:
Citation
[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.
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Emotions Immunology and Breast Cancer

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