Psychological Resources Buffers of the Association Between Financial Toxicity and Quality of Life: A Longitudinal Study of Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Change in Quality of life
研究概览
简要总结
Breast cancer survivors face significant financial stress (also called financial toxicity) due to the high costs of cancer treatment. This financial stress can worsen quality of life. Previous studies have demonstrated that breast cancer survivors may draw on inner psychological strengths to cope effectively. This study aims to examine whether psychological resources, specifically resilience and posttraumatic growth (PTG), buffer the longitudinal association between financial toxicity and quality of life (QoL) among breast cancer survivors.
Hypotheses: H1: Financial toxicity is negatively associated with QoL over time. H2: Resilience moderates the association between financial toxicity and QoL, such that higher resilience attenuates the negative impact of financial toxicity.
H3: Posttraumatic growth (PTG) moderates the association between financial toxicity and QoL, such that moderate to high levels of PTG attenuate the negative impact of financial toxicity.
Participants will complete questionnaires at three time points: before their first chemotherapy cycle, at two months (mid-treatment), and at four months (end of chemotherapy). The questionnaires measure financial stress, quality of life, resilience, and posttraumatic growth.
The study plans to enroll at least 160 participants. Data will be analyzed using statistical methods that track changes across time and test whether resilience and posttraumatic growth buffer the impact of financial stress on quality of life. All data will be de-identified and stored securely.
详细描述
Background:
Breast cancer is the most prevalent malignancy among women worldwide. In China, five-year survival rates have reached approximately 83%, making breast cancer survivors the largest cancer survivor group. Quality of life (QoL) has emerged as a key patient-centered outcome in oncology. Survivors undergoing chemotherapy commonly experience impaired physical function, psychosocial difficulties, and treatment-related symptoms that adversely affect QoL.
Financial toxicity encompasses both the objective financial burden and subjective financial distress arising from cancer-related costs. National survey data indicate that 82.6% of breast cancer survivors in China experience financial toxicity, with 40.9% reporting severe levels. Financial toxicity has been associated with treatment non-adherence, delayed care, and poorer QoL. A meta-analysis of 31 studies found a moderate negative association between financial toxicity and QoL. Survivors undergoing active treatment report higher financial toxicity than those who have completed therapy.
Psychological Resources:
Resilience is conceptualised as the capacity to adapt in the face of adversity, trauma, or significant stressors, which is linked to better QoL in cancer populations. A meta-analysis of 66 studies found that higher resilience was significantly associated with better QoL. Emerging cross-sectional evidence suggests that resilience partially mediates the association between financial toxicity and QoL; however, its longitudinal buffering role remains unclear.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed diagnosis of breast cancer
- •Aware of their diagnosis
- •Able to read and complete the questionnaire
- •Scheduled to undergo a standard chemotherapy regimen
排除标准
- •History of severe psychiatric disorders (e.g., schizophrenia or bipolar disorder)
- •Another prior cancer diagnosis
- •Evidence of distant metastasis (stage IV disease)
- •Severe comorbid conditions that could interfere with study participation or outcomes (e.g., severe cardiovascular disease or cognitive impairment)
研究组 & 干预措施
Breast Cancer Survivors Undergoing Chemotherapy
Breast cancer survivors receiving chemotherapy at Henan Cancer Hospital are assessed by questionnaire at three time points during chemotherapy to examine the relationships among financial toxicity, psychological resources (resilience and posttraumatic growth), and quality of life.
结局指标
主要结局
Change in Quality of life
时间窗: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
The Chinese version of the Functional Assessment of Cancer Therapy-General (FACT-G) is a validated 27-item instrument used to assess health-related quality of life. It comprises four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The instrument has demonstrated good reliability, with Cronbach's α coefficients exceeding 0.80 for all domains. Total scores range from 0 to 108, with higher scores indicating better quality of life.
次要结局
- Change in Financial Toxicity(Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy))
- Change in Resilience(Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy))
- Change in Posttraumatic Growth(Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy))
研究者
Qian Guo
Principal Investigator
Okayama University