The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life
研究概览
简要总结
A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. This study aims to assess the effect of a combined lifestyle intervention for patients with cancer on quality of life.
详细描述
A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. The aim of this study is to assess the effect of a combined lifestyle intervention for patients with cancer, who suffer from the consequences of cancer and its treatment, on quality of life.
The GLINK study is a pragmatic randomized controlled trial with two study arms: an intervention (n=122)- and a control arm (n=122).
The investigators will recruit 244 cancer patients who have a reduced quality of life. Participants will be either within five years post-primary treatment OR have advanced cancer (stage IV) with a prolonged life expectancy. Patients in the intervention arm will be offered a combined lifestyle intervention guided by a lifestyle coach or oncology physiotherapist and oncology nurse. The intervention consists of an intensive intervention phase of 6 months and a maintenance phase of another 6 months. The control patients will receive four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.
The primary endpoint is quality of life. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with an invasive or hematological cancer type and either within five years post-primary treatment with curative intent OR having advanced cancer (stage IV) with a prolonged life expectancy (chronic cancer patients) . Primary treatment in this context, includes among others surgery (> 3 months ago), radiotherapy, and/or chemotherapy or a stem cell transplant in case of hematological cancers.
- •Report a reduced HRQoL, i.e., a low score on at least 2 of the functioning scales and/or the symptom scale fatigue of the EORTC-QLQ-30 based on the thresholds of clinical importance of Giesinger et al. (2020)
- •Be 40 years of age or older. The investigators have chosen this cut-off because they believe that younger cancer patients (AYA's) face different challenges and should not be mixed with the average older patient. This approach ensures greater homogeneity within the study population.
- •Be able to speak and understand Dutch
排除标准
- •Following, or planned to follow a combined lifestyle intervention (i.e., one of the existing interventions for overweight) during the intervention period
- •Patients in the terminal phase (life expectancy < 3 months)
- •Mental or behavioural problems that hinder participating in group lifestyle coaching indicated by the health care professional who is referring to GLINK or by the study team
- •Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team or treating physician
研究组 & 干预措施
Intervention group
Following a combined lifestyle intervention for 12 months
干预措施: combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse (Behavioral)
Control group
Receiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.
干预措施: short online lifestyle intervention by lifestyle coach and educational materials after 6 months (Behavioral)
结局指标
主要结局
Health Related Quality of Life
时间窗: Measured at 0, 6 and 12 months
Summary score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This questionnaire consists of five functioning scales (physical, emotional, role, cognitive and social functioning), three symptom scales (fatigue, nausea \& vomiting) and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-C30 summary score ranges from 0 to 100, with higher scores indicating better health-related quality of life. This summary score is calculated as the mean of all scale scores (excluding global QoL and financial difficulties).
次要结局
- Health-Related Quality of Life - separate functioning and symptom scales(Measured at 0, 6 and 12 months)
- Cancer-related fatigue(Measured at 0, 6 and 12 months)
- Sleep Hygiene(Measured at 0, 6 and 12 months)
- Positive Health(Measured at 0, 6 and 12 months)
- Height(Measured at 0 and 6 months)
- Weight(Measured at 0 and 6 months)
- Waist circumference(Measured at 0 and 6 months)
- Body composition(Measured at 0 and 6 months)
- Physical activity - questionnaire(Measured at 0, 6 and 12 months)
- Physical activity - tracker(Measured at 0 and 6 months. The device will be worn for nine consecutive days, on the right mid-thigh, attached with adhesive tape.)
- Diet components(Measured at 0, 6 and 12 months)
- Pack years of smoking(Measured at 0, 6 and 12 months)
- Smoking status(Measured at 0, 6 and 12 months)
- Cost-effectiveness - EuroQol(EQ)-5D-5L(Measured at 0, 6 and 12 months)
- Health care costs(Measured at 0, 6 and 12 months)
- Costs of Productivity loss(Measured at 0, 6 and 12 months)
- Costs of informal care(Measured at 0, 6 and 12 months)
- Health literacy(Measured at 0, 6 and 12 months)
研究者
Kristel van Asselt
Epidemiologist and general practitioner
UMC Utrecht