Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,183
- 试验地点
- 1
- 主要终点
- Fatigue severity
研究概览
简要总结
The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding cancer-related fatigue from the institutional, professionals' and patients' perspective.
详细描述
The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding fatigue from the institutional, professionals', and patients' perspective. With a multimodal approach including a comprehensive assessment of fatigue management and support offered by different institutions (uncertified hospitals, uncertified oncological practices, counselling units, certified cancer centers; n=350), a survey and qualitative interviews among practicing physicians ("Niedergelassene Ärzte"), hospital physicians, practicing psychotherapists with psycho-oncological focus, psycho-oncologists at hospitals, nurses at certified cancer centers and nurses at other hospitals (n=420), and a longitudinal clinical study among cancer patients (n=1400) as well as two focus groups with patient representatives (each n=6), the characteristics, patterns, and potential effects or shortcomings of the current fatigue management will be investigated. Furthermore, factors associated with patients' and health care professionals' knowledge about fatigue will be examined.
Concerning the longitudinal clinical study assessing the patients' perspective, online or paper-based questionnaires on socio-demographic, clinical and patient reported outcomes will be sent to the patients 6,9,12 and 24 months after diagnosis. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.
The results of the LIFT project shall provide a basis to identify and overcome shortcomings in the actual fatigue management in Germany, and, to eventually ameliorate this severe burden in cancer patients and survivors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Newly diagnosed with a primary tumor of one of the following malignant neoplasms: colon (C18), rectum (C19-20), liver (C22), pancreas (C25), lung (C33-34), malignant melanoma (C43), breast (C50, only female), cervix (C53), endometrium (C54.1), ovaries (C56), prostate (C61), kidney (C64), bladder (C67), thyroid gland (C73), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95)
- •Having received or receiving at enrolment at least one of the following treatments: chemotherapy, radiotherapy, hormone therapy, targeted or immune therapy
- •Able to understand and follow the study protocol
排除标准
- •Carcinoma in situ
- •Any additional malignant or unclear neoplasm before or since time of diagnosis of the considered primary tumor, except unspecified neoplasm of skin (C44)
结局指标
主要结局
Fatigue severity
时间窗: 6 months after diagnosis to 2 years post-diagnosis
assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire). The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue.
State of fatigue management
时间窗: 6 months after diagnosis to 2 years post-diagnosis
Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue.
Impact of fatigue
时间窗: 6 months after diagnosis to 2 years post-diagnosis
assessed by the Brief Fatigue Inventory (BFI). The BFI consists of an 11-point numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine) with higher scores signifying higher intensity and impairment.
Knowledge, attitudes and beliefs regarding cancer-related fatigue
时间窗: 6 months after diagnosis to 2 years post-diagnosis
Questionnaire assessing knowledge, attitudes and beliefs regarding cancer-related fatigue. The knowledge score consists of fatigue-related statements that should be rated as either right, wrong, or "dont know". The attitudes scale is composed of statements that should be rated on a 4-point likert scale. Higher scores indicate a greater agreement to the particular statement.
次要结局
- Quality of life functions and symptoms(6 months after diagnosis to 2 years post-diagnosis)
- Sleep problems(6 months after diagnosis to 2 years post-diagnosis)
- Supportive Care Needs(assessed at t2 9 months post-diagnosis)
- Patient Activation(at t2 (9 months post-diagnosis))
- Body mass index(6 months, 12 months and 24 months post-diagnosis)
- Return to work(6 months, 12 months and 24 months post-diagnosis)
- Social Support(at t1 (6 months post-diagnosis) and t3 (12 months post-diagnosis))
- Depression(6 months after diagnosis to 24 months post-diagnosis)
- Total physical activity(6 months, 12 months and 24 months post-diagnosis)
- Anxiety(assessed 6 months after diagnosis to 24 months after diagnosis)
- Loneliness(at t1 (6 months post-diagnosis) and t4 (24 months post-diagnosis))
- Resilience(assessed at t1 6 months post-diagnosis)
- Posttraumatic growth(at t4 (24 months post-diagnosis))