About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Severe neurologic or cardiac impairment according to ACSM criteria
Trial design
Parallel
Treatments tested in this trial
Exercise group
BehavioralLive-remote exercise sessions, personalized to the patients main side-effect
Treatment groups
Trial outcomes
Primary outcomes
Health-Related Quality of Life
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
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..
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 2: Anxiety and depressive symptoms measured with Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 3: Physical functioning measured with EORTC QLQ-C30 physical function scale According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
Secondary outcomes
Health-related quality of life
Domains of the EORTC QLQ-C30 (except summary score)
Fatigue
Cancer-Related fatigue measured with the EORTC-FA12
Anxiety and Depression
Anxiety and depressive symptoms measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
CIPN_1
Chemotherapy-induced peripheral neuropathy measured with EORTC QLQ-CIPN-20
Other outcomes
Participants experience of sensor-based guidance
Questionnaires - substudy control patients Cologne
Trainer experience of sensor-based guidance
Questionnaires - substudy control patients Cologne
Compliance sensor-based guidance
% of sessions that patients wear the sensor - substudy control patients Cologne
Technical feasibility of sensor-based guidance
% of successful live transfer of sensor data - substudy control patients Cologne
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
German Cancer Research Center
Collaborator
German Sport University, Cologne
Collaborator
Cabrini Health (CAB), Malvern, Australia
Collaborator
Karolinska Institute (KI), Stockholm, Sweden
Collaborator
The Netherlands Cancer Institute
Collaborator
Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany
Collaborator
Fundacion Onkologikao (ONK), San Sebastian, Spain
Collaborator
Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal
Collaborator