protocolSection identificationModule nctId: NCT06270628, orgStudyIdInfo id: NL85029.018.23, briefTitle: Personalized Live-remote Exercise Training for Cancer Survivors, acronym: LION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: German Cancer Research Center (DKFZ), Heidelberg, Germany, collaborators name: German Sport University Cologne (DSHS), Cologne, Germany, collaborators name: Cabrini Health (CAB), Malvern, Australia, collaborators name: Karolinska Institute (KI), Stockholm, Sweden, collaborators name: Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands, collaborators name: Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany, collaborators name: Fundacion Onkologikao (ONK), San Sebastian, Spain, collaborators name: Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal, descriptionModule briefSummary: BackgroundMany 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 studyIn 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.MeasurementsThe 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., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT with two study arms: exercise group and wait list control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Exercise group, outcomesModule primaryOutcomes measure: Health-Related Quality of Life, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: CIPN_1, secondaryOutcomes measure: CIPN_2, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Pain, secondaryOutcomes measure: Cognitive problems, secondaryOutcomes measure: Work limitations, secondaryOutcomes measure: Body image, secondaryOutcomes measure: Fear of cancer recurrence, secondaryOutcomes measure: Habitual physical activity, secondaryOutcomes measure: Aerobic capacity on bike, secondaryOutcomes measure: Aerobic capacity on step, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Upper body muscle strength, secondaryOutcomes measure: Lower body muscle strength, secondaryOutcomes measure: Sit to stand test, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Resting heart rate, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Inflammatory state, secondaryOutcomes measure: Growth factors, secondaryOutcomes measure: CRP, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leucocyte counts, secondaryOutcomes measure: Quality-adjusted life years, secondaryOutcomes measure: Health-care, patient and family costs, secondaryOutcomes measure: Productivity losses, secondaryOutcomes measure: Exercise-related (serious) adverse events, otherOutcomes measure: Participants experience of sensor-based guidance, otherOutcomes measure: Trainer experience of sensor-based guidance, otherOutcomes measure: Compliance sensor-based guidance, otherOutcomes measure: Technical feasibility of sensor-based guidance, otherOutcomes measure: Aerobic capacity, otherOutcomes measure: Upper body muscle strength, otherOutcomes measure: Lower body muscle strength, otherOutcomes measure: Core muscle strength, otherOutcomes measure: Physical functioning, otherOutcomes measure: Balance, otherOutcomes measure: Socio-demographics, otherOutcomes measure: Self-efficacy, otherOutcomes measure: Social Support, otherOutcomes measure: Medical history, otherOutcomes measure: Concomitant diseases, otherOutcomes measure: Cancer + concomitant medication, otherOutcomes measure: Cancer characteristics, otherOutcomes measure: Cancer treatment history, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Utrecht, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False