Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female: an Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Trajectory of Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
研究概览
简要总结
When receiving adjuvant chemotherapy, a variety of symptoms will appear and it is very painful. These symptoms occur at the same time and are related to each other. The symptom distress may affect the patient's compliance with adjuvant chemotherapy and whether the adjuvant chemotherapy can be completed on schedule. Among the symptoms of trouble, cancer-related fatigue is the most common, and the incidence can be as high as 99%. In this study, I want to track the population of breast cancer patients receiving adjuvant chemotherapy, and women in the control group who receive only anti-hormonal breast cancer or carcinoma in situ. During the treatment period, at different time points, it also collects subjective symptom distress changes and changes. The study aimed cancer-related exhaustion is measured to gain a deeper understanding of the effects of symptom troubles suffered by patients during treatment. We also hoped that in the future, it can be provided to colleagues in clinical work and can be given to breast cancer patients receiving adjuvant chemotherapy and increased holistic care quality.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The surgical pathological tissue report confirms that the diagnosis is zero stage breast carcinoma in situ women and stage I~III Breast cancer women.
- •Those who are admitted to the hospital for the first time adjuvant chemotherapy or hormonal therapy.
- •Age (inclusive) over 20 years old
排除标准
- •Women with breast cancer who are unconscious or unable to express.
结局指标
主要结局
Trajectory of Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
FACT-B;multidimensional questionnaire with 37 items that build 5 dimensions (subscales) when using a 5-point Likert scale. (from 0, not at all through 4, very much) that constitute 5 dimensions.
Trajectory of ISI: Insomnia Severity Index
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
(ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.11,24 The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Trajectory of Symptom distress
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
Edmonton Symptom Assessment Scale, ESAS; including nine symptoms, one symptom range from 0-10, total score 0-90.
Trajectory of PHQ-4: Validated Screening Tool for Anxiety and Depression
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
PHQ-4;PHQ-4 Scoring: Total score ranges from 0 to 12, with categories of psychological distress as follows: None: 0-2; Mild: 3-5; Moderate: 6-8; Severe: 9-12; Anxiety subscale = sum of items 1 and 2 (score range: 0 to 6) Depression subscale = sum of items 3 and 4 (score range: 0 to 6) On each subscale, a score of 3 or greater is considered positive for screening purposes.
Trajectory of fatigue
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
Brife fatigue inventory, BFI; including nine items, total score 0-10.
Trajectory of distress temperature
时间窗: T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;
Distress Thermometer, DT; range from 0-10.
次要结局
未报告次要终点
研究者
Tsai-Wei Huang
School of Nursing
Taipei Medical University