Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Hemagglutination inhibition assay (HAI) - Fold response to IV
研究概览
简要总结
The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"
- •No prior history of cancer (with the exception of non-melanoma skin cancer)
- •Life expectancy of > 12 months.
- •No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans.
- •No substance dependency in the past 12 months.
- •No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)
- •No prior neo-adjuvant therapy
- •No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)
- •No significant cognitive impairment, must score <31 on the Telephone Interview for Cognitive Status (TICS)
- •At least a 6th grade reading level in English and be available for follow-up
- •Women age 50 and older diagnosed with stage 0-III breast cancer.
排除标准
- •Does not meet all Inclusion Criteria.
研究组 & 干预措施
R-CBSM
10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
干预措施: R-CBSM (Behavioral)
R-CBSM
10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
干预措施: Influenza vaccine (Biological)
Wait List Condition (WLC)
Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
干预措施: R-CBSM (Behavioral)
Wait List Condition (WLC)
Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Hemagglutination inhibition assay (HAI) - Fold response to IV
时间窗: 28 days post vaccine
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
时间窗: 28 days post vaccine
Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.
次要结局
- Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)(Baseline (T0) to 6 months (T1).)
- Magnitude of Immune changes associated with Flu Vaccine response(Baseline (T0) to 28-day post IV (T3))
- Change in Circulating Cytokine levels(Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3))
- Change in Affective Status markers(Baseline (T0) to 28-day post IV (T3).)
- Change in Affective Status(Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).)
- Change in Immune Status measured by Switched B-cells (swB)(Baseline (T0) to 28-day post IV (T3).)
- Magnitude of Inflammatory changes associated with Flu Vaccine response(Baseline (T0) to 28-day post IV (T3))
研究者
Michael H. Antoni
Professor
University of Miami