A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
研究概览
简要总结
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.
详细描述
Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking.
Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom.
The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion.
The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway.
All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Survivors of Hodgkin and aggressive non-Hodgkin lymphoma
- •Not indolent non-Hodgkin lymphoma
- •Not CNS lymphoma at diagnosis
- •Not second cancer
- •Not ongoing cancer treatment
- •Chronic fatigue measured by Chalder Fatigue Questionnaire
- •Diagnosed 2010-2020
- •Received treatment with curative intent
- •18 - 70 years old at inclusion
- •> 2 years since last treatment
- •Able to understand the Norwegian language
- •Participation approval from oncologist in the project group
排除标准
- •Persisting fatigue > 1 year before the cancer diagnosis
- •Somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches)
- •Psychiatric or mental disorders (i.e. dementia, severe depression, schizophrenia)
- •Use of stimulants for ADHD
- •Substance abuse disorder
结局指标
主要结局
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
时间窗: From baseline (T0) to 12 weeks (T1)
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.
次要结局
- Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire(From post-intervention (T1) to 24-month follow-up (T5))
- Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).(From post-intervention (T1) to 24-month follow-up (T5))
- Difference in change in work ability between groups assessed by the Work Ability Index scale(From baseline (T0) to 36 weeks (T3))
- Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job(From post-intervention (T1) to 24 months follow-up (T5))
- Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test(From baseline (T0) to 36 weeks (T3))
- Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.(From baseline (T0) to 36 weeks (T3))
- Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.(From post-intervention (T1) to 24 months follow-up (T5))
- Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).(From baseline (T0) to 36 weeks (T3))
- Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).(From baseline (T0) to 36 weeks (T3))
- Change in work ability in both groups assessed by the Work Ability Index scale(From post-intervention (T1) to 24 months follow-up (T5))
- Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job(From baseline (T0) to 36 weeks (T3))
- Difference in change in lower body muscle strength between groups assessed by leg press(From baseline (T0) to 36 weeks (T3))
- Difference in change in lower body muscle strength between groups assessed by push-ups(From baseline (T0) to 12 weeks (T1))
- Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).(From baseline (T0) to 36 weeks (T3))
- Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).(From baseline (T0) to 24 months follow-up weeks (T5))
- Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ(From baseline (T0) to 12 weeks (T1))
- Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).(From post-intervention (T1) to 24-month follow-up (T5))
- Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job(From post-intervention (T1) to 24 months follow-up (T5))
- Difference in change in upper body muscle strength between groups assessed by push-ups(From baseline (T0) to 36 weeks (T3))
- Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.(From baseline (T0) to 36 weeks (T3))
- Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale(From baseline (T0) to 36 weeks (T3))
- Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire(From baseline (T0) to 36 weeks (T3))
- Difference in change in work status between groups assessed by questions from the HUNT4-study(From baseline (T0) to 36 weeks (T3))
- Change in work status in both groups assessed by questions from the HUNT4-study(From post-intervention (T1) to 24 months follow-up (T5))
- Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)(From baseline (T0) to 36 weeks (T3))
- Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9(From baseline (T0) to 36 weeks (T3))
- Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9(From post-intervention (T1) to 24-month follow-up (T5))
- Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)(From baseline (T0) to 36 weeks (T3))
- Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job(From baseline (T0) to 36 weeks (T3))
- Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).(From baseline (T0) to 36 weeks (T3))
- Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ(From baseline (T0) to 36 weeks (T3))
- Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)(From baseline (T0) to 36 weeks (T3))
- Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).(From baseline (0) to 36 weeks (T3))
- Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway(At 12- and 24-month follow-up)
- Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions(At 12- and 24-month follow-up)
研究者
Lene Thorsen
Principal Investigator
Oslo University Hospital