Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).
研究概览
简要总结
Cancer-related fatigue is highly prevalent in patients with cancer receiving palliative treatment and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited.
The goal of this interventional study is to integrate interdisciplinary web-based CBT (inter-CBT) into clinical practice and prove non-inferiority in achieving a reduction in fatigue compared to face-to-face- CBT in patients with cancer receiving palliative treatment.
The main aims to answer are:
- To determine the non-inferiority of inter-CBT, compared to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.
- To adapt CBT delivery to the needs of patients treated with palliative intent (interdisciplinary web-based CBT for cancer-related fatigue.
- To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers.
Participant will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes.
Researchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.
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
- •Receive systemic treatment with palliative intent for a solid tumor.
- •Treatments include chemotherapy, targeted therapy, immunotherapy, and hormone therapy, possibly combined with surgery and/or radiation therapy
- •Are ≥18 years old
- •Are proficient in Dutch
- •Report severe fatigue (Checklist Individual Strength, fatigue severity subscale [CIS-fatigue] score ≥35) with no known somatic explanation other than cancer and/or cancer treatment
- •A life expectancy of ≥6 months according to their oncologist
- •Access to a device with internet.
排除标准
- •Symptomatic brain metastases
- •Have a poor performance status (Karnofsky <70)
- •Are currently receiving treatment for a mental disorder.
研究组 & 干预措施
Benchmark study
The results will be compared with those of a benchmark study, i.e. historical cohort of the same target group who received face-to-face CBT provided by psychologists in the TIRED study.
干预措施: Cognitive behavioral therapy (Behavioral)
结局指标
主要结局
Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).
时间窗: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
The CIS-fatigue has shown to be sensitive to change, has good reliability and discriminative validity. Scores range from 8 to 56. A score of ≥35 indicates severe fatigue. Change = (week 14 score - baseline score).
次要结局
- Functional impairment will be measured using the subscales emotional functioning (4 items, 4-point Likert scale) and physical functioning (5 items, 4-point Likert scale, range 0 to 100) of the EORTC QLQ-C30.(Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2))
- Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30.(Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2))
- Healthcare consumption(Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2))
- Functional impairment will be assessed with the work and social adjustment scale (WSAS)(Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2))
- Fatigue will be assessed with the symptom scale Fatigue ((3 items, 4-point Likert scale) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0).(Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2))
研究者
Hans Knoop
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)