跳至主要内容
临床试验/NCT06855654
NCT06855654招募中不适用

Evaluating Psychological and Survival Outcomes of the Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC) Intervention

UNC Lineberger Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Resilience Score Change

研究概览

简要总结

This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population.

Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.

详细描述

Black women with breast cancer have substantially worse survival compared to White counterparts across all stages of presenting disease. Survival from a diagnosis of metastatic breast cancer (MBC) to death is shorter for Black compared to non-Black women, with the worst disparity appearing in younger patients.

Black compared to non-Black MBC patients also report more chronic stressors including social barriers to cancer care, metabolic co-morbidities, and higher likelihood of residing in neighborhoods with adverse social determinants of health (SDOH). These bio-psycho-social factors are potential mechanisms of observed racial gaps in survival of MBC. The adversity experienced by Black patients may impact the outcomes of MBC through social, psychological, and biological mechanisms. Regarding social mechanisms, adverse SDOH may cause patients to have delays in care, miss appointments, defer needed treatment, or tolerate treatment less well due to unmet supportive care or social support needs. Regarding psychological and biological mechanisms, cumulative physiologic stress and distress elevate inflammatory and immune biomarkers and precipitate the development of cardio-metabolic diseases, a phenomenon known as allostatic overload. Black individuals both with and without cancer are more likely to suffer from allostatic overload, and the impact of cancer on allostatic load may be differential by race. While the Black-White gap in breast cancer survival has long been recognized, the relationships among marginalized racial identity, adverse social circumstances, allostatic overload, and breast cancer outcomes remain poorly understood.

Stress and Coping Theory posits that the ways in which individuals appraise and cope with stressful experiences are modifiable targets for intervention. In this regard, "resilience" is a key construct; it implies an ability to harness resources to sustain well-being in the face of adversity. In breast cancer patients and others with serious illness, skills in stress-management, goal-setting, positive-reframing, and meaning - making are associated with improved stress biology, physical, and mental health. In the context of an advanced cancer diagnosis, resilient individuals may be more able to cope with the challenges of illness, including barriers to care, and in turn experience less incremental stress, and improved quality of life (QOL) and disease outcomes. Such resilience might be particularly beneficial to patients from marginalized groups.

Investigators of this study have previously developed and demonstrated the efficacy of a targeted intervention promoting resilience in populations of young adults with pediatric cancers and advanced cancers. However, evidence is lacking as to whether such an intervention can be helpful among women with MBC, particularly those from historically marginalized communities. The goal of this study is to test the impacts of a remotely delivered resilience intervention, Promoting Resilience in Stress Management (PRISM), on relevant social, psychological, and biologic outcomes of diverse women with a recent diagnosis of MBC at the University of North Carolina-Chapel Hill (UNC) and the University of Alabama-Birmingham (UAB).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • •Participants are willing and able to comply with study procedures based on the judgement of the investigator.
  • •Male and female patients of age >18 years.
  • •Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
  • •Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
  • •Indicate intent to receive ongoing cancer care at the enrolling institution.

排除标准

  • •Individuals meeting any of the following exclusion criteria will be excluded from study participation.
  • •Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer.
  • •Patient unwilling or unable to provide verbal or signed consent to participate.
  • •Participant cannot read English.
  • •Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.

研究组 & 干预措施

PRISM

Experimental

Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention.

干预措施: Promoting Resilience in Women with Breast Cancer (PRISM) (Behavioral)

结局指标

主要结局

Resilience Score Change

时间窗: Baseline and 3 months

Resilience Score Change will be assessed baseline to 3 months using Connor Davidson Resilience Score, overall and stratified by race (Black/non-Black).

次要结局

  • Change in allostatic load index (ALI)(Baseline and 12 months)
  • Time to progression(Baseline and 12 months)
  • Survival(Baseline and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Promoting Resilience in Women With Breast Cancer... | 临床试验