Clinical trial NCT03609671: Emotions Immunology and Breast Cancer
Official title: A Pilot Study: Emotions Immunology and Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Triple Negative Breast Cancer
Emotions
Immunology
Keywords: Breast Cancer
Emotions Immunology
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to two groups.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Questionnaire#1, Adverse Childhood Experience (ACE).
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
measure: Questionnaire#2, Depression, Anxiety, and Stress Scale (DASS).
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
measure: Questionnaire#3, Experiences in Close Relationships-Revised (ECR-R).
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
measure: Questionnaire#4, Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4).
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
measure: Questionnaire#5, Benefit Finding Scale (BFS).
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
measure: Questionnaire#6, Acceptance and Action Questionnaire - II (AAQ-II)
timeFrame: Baseline pre-chemotherapy and post-chemotherapy (about 4-6 months later).
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital Cancer Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Luz A. Venta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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