Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
Background
Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.
Goal of the study:
The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.
Design of the study
In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.
The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.
Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.
Measurements
The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.
Conclusion:
This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.
详细描述
SUMMARY
Rationale:
Many cancer patients suffer from long-term treatment-related side-effects like fatigue, low physical functioning, anxiety and/or depressive symptoms, and chemotherapy-induced peripheral neuropathy (CIPN). There is convincing evidence on the beneficial effects of general exercise interventions on these side-effects. However, studies to date generally fail to specifically screen for (long-term) side-effects at baseline and tailor the intervention to these specific side-effects, although larger exercise effects are observed in patients with a high symptom burden at baseline (e.g., with higher levels of fatigue). Larger effects of exercise are also observed for supervised exercise compared to unsupervised exercise. However, two of the most common barriers for attending and complying with supervised exercise are travel distance and time. An effective approach might be to provide live-remote supervision for exercise interventions. In this scenario, patients can receive guidance from a certified exercise specialist through a video-conferencing platform such as Zoom, while performing exercises within the comfort of their own homes. Currently, the effectiveness of live-remote exercise in cancer patients has not been established.
Objective:
The primary objective of the LION RCT is to assess the (cost-)effectiveness of a personalized, live-remote exercise intervention for cancer survivors on Health-Related Quality of Life (HRQOL) and the participants' main, self-reported side-effect. The four side-effects targeted in this study are: 1) fatigue, 2) perceived low physical functioning in daily life, 3) anxiety and/or depressive symptoms, and 4) CIPN.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, a subject must be:
- •18 years of age or older
- •Diagnosed with any type of invasive cancer and have received systemic chemotherapy as part of their primary cancer treatment
- •Within the timeframe of 12 weeks to 1 year after the completion of their primary cancer treatment with curative intent. Primary treatment, in this context, includes surgery, radiotherapy, and/or chemotherapy. For patients undergoing endocrine, targeted, or immunotherapy, their treatment must not be scheduled to be discontinued within the next 6 months.
- •No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease in the regular clinical trajectory)
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- •Presence of at least one of the following side-effects: fatigue (measured using EORTC QLQ-C30 fatigue symptom scale, score >39), perceived low physical functioning in daily life (measured using EORTC QLQ-C30 physical functioning scale, score <83), anxiety or depressive symptoms (measured using PHQ-ADS > 20), and/or CIPN (measured using 2 PRO-CTCAE items, score >0) for patients who received neurotoxic chemotherapy. Cut-off values are based on established thresholds.19-21
- •Access to good quality and stable internet connection to access the live-remote training sessions.
- •Able and willing to perform the exercise program and wear the activity tracker at least one week after T0 and before T2, T4, and T5 measurements and during training and online assessment sessions.
- •Able to read, speak and understand the main country language.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Too physically active (i.e., >210 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities; this threshold has also been used in other exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all participating countries) or participation in an exercise program comparable to the LION exercise program.
- •Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
- •Participated in the intervention group of an exercise study during cancer treatment
- •Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including:
- •Severe neurologic or cardiac impairment according to ACSM criteria
- •Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise
- •Uncontrolled pain All these exclusion criteria are formulated to ensure safe participation in the LION exercise program
- •Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the treating physician
- •More than 1 week not able to attend training sessions during the LION intervention period
研究组 & 干预措施
Exercise group
Participants will be offered three live-remote exercise training sessions per week. Each participant in the trial will be provided with the base module twice a week, which will involve a personalized training intensity. This module aims at targeting the participants' HRQOL, which is the first primary endpoint of the trial. Additionally, each participant will receive one out of four specific modules once a week to address their individual main side-effect (based on shared decision-making (SDM)) (second primary outcome). The intervention also includes an educational component about exercise and cancer.
干预措施: Exercise group (Behavioral)
Wait list control group
Regular care The control group will receive the same exercise program after the 12 weeks intervention period
结局指标
主要结局
Health-Related Quality of Life
时间窗: Week 0 - Week 12
Measured with the summary scale of the EORTC QLQ-C30; min 0- max 100 points; higher scores mean better quality of life
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
时间窗: Week 0 - Week 12
Side-effect 1: Fatigue measured with EORTC QLQ-FA12. According to a standardization procedure the symptom score of all patients will be combined into one symptom score..
次要结局
- Health-related quality of life(Week 0 - Week 36)
- Fatigue(Week 0 - Week 36)
- Anxiety and Depression(Week 0 - Week 36)
- CIPN_1(Week 0 - Week 36)
- CIPN_2(Week 0 - Week 36)
- Sleep(0-36 weeks)
- Pain prevalence and type(Week 0 - Week 36)
- Cognitive problems(Week 0 - Week 36)
- Work limitations(Week 0 - Week 36)
- Body image(Week 0 - Week 36)
- Fear of cancer recurrence(0-36 weeks)
- Habitual physical activity(Week 0 - Week 36)
- Aerobic capacity on bike(Week 0 - Week 24)
- Aerobic capacity on step(Week 0 - Week 24)
- Lower body muscle strength(0-24 weeks)
- Handgrip strength(Week 0 - Week 24)
- Upper body muscle strength(Week 0 - Week 24)
- Sit to stand test(Week 0 - Week 24)
- Physical function(Week 0 - Week 24)
- Balance(Week 0 - Week 24)
- Physical activity(0-36 weeks)
- Blood pressure(0-24 weeks)
- Resting heart rate(Week 0 - Week 24)
- Weight(Week 0 - Week 24)
- Height(Week 0 - Week 24)
- Waist circumference(Week 0 - Week 24)
- Hip circumference(Week 0 - Week 24)
- Body composition(Week 0 - Week 24)
- Inflammatory state(0-12 weeks)
- Growth factors(0-12 weeks)
- CRP(Week 0 - Week 12)
- Hemoglobin(0-12 weeks)
- Leucocyte counts(0-12 weeks)
- Quality-adjusted life years(Week 0 - Week 36)
- Health-care, patient and family costs(Week 0 - Week 36)
- Productivity losses(Week 0 - Week 36)
- Exercise-related (serious) adverse events(Week 0 - Week 36)