Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-15
Brief Title:
Personalized Live-remote Exercise Training for Cancer Survivors
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Demonstrating the Cost-Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial the LION RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LION
Brief Summary:
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 andor 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 andor depressive symptoms andor 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
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 andor 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 andor depressive symptoms andor 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
Detailed Description:
SUMMARY
Rationale
Many cancer patients suffer from long-term treatment-related side-effects like fatigue low physical functioning anxiety andor 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 eg 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 andor depressive symptoms and 4 CIPN
Study design
The LION RCT is a randomized controlled trial with two study arms an exercise group 12 weeks and a wait list control group A super umbrella design will be used allowing us to evaluate four exercise modalities ie exercise modules based on participants main side-effect in a wide variety of cancer survivors
Study population
For this study 350 adult cancer survivors treated with systemic chemotherapy 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent will be recruited independent of their primary cancer diagnosis Participants will have reported at least one of the following side-effects fatigue low physical functioning in daily life anxiety andor depressive symptoms CIPN Additionally participants need to be relatively physically inactive ie perform 210 minutesweek of moderate-to-vigorous leisure and sports activities
Intervention
The intervention consists of three live-remote exercise sessions per week Participants randomized to the exercise group receive the intervention after the baseline visit and the wait list control participants after the 12-week follow-up visit A modular approach will be used to tailor the intervention to each participants specific main side-effect Each participant will receive the same base module twice a week to address HRQOL and in addition one out of four specific modules once a week addressing their individual main side-effect In addition to the live-remote training participants will be provided with the LION app and an activity tracker Fitbit at the start of the intervention to support exercise beyond the supervised program during holidays and after the end of the intervention In addition to exercise the intervention also has an educational component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects We consider the provision of such education as an integral part of adequate exercise programming
After the intervention period of 12 weeks we follow the patients until 36 weeks In this follow-up period also two sub studies take place
1 Sensor-based guidance sub study only control patients from Cologne
2 Live-remote physical fitness and function testing in all control patients all sites
Rationale
Many cancer patients suffer from long-term treatment-related side-effects like fatigue low physical functioning anxiety andor 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 eg 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 andor depressive symptoms and 4 CIPN
Study design
The LION RCT is a randomized controlled trial with two study arms an exercise group 12 weeks and a wait list control group A super umbrella design will be used allowing us to evaluate four exercise modalities ie exercise modules based on participants main side-effect in a wide variety of cancer survivors
Study population
For this study 350 adult cancer survivors treated with systemic chemotherapy 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent will be recruited independent of their primary cancer diagnosis Participants will have reported at least one of the following side-effects fatigue low physical functioning in daily life anxiety andor depressive symptoms CIPN Additionally participants need to be relatively physically inactive ie perform 210 minutesweek of moderate-to-vigorous leisure and sports activities
Intervention
The intervention consists of three live-remote exercise sessions per week Participants randomized to the exercise group receive the intervention after the baseline visit and the wait list control participants after the 12-week follow-up visit A modular approach will be used to tailor the intervention to each participants specific main side-effect Each participant will receive the same base module twice a week to address HRQOL and in addition one out of four specific modules once a week addressing their individual main side-effect In addition to the live-remote training participants will be provided with the LION app and an activity tracker Fitbit at the start of the intervention to support exercise beyond the supervised program during holidays and after the end of the intervention In addition to exercise the intervention also has an educational component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects We consider the provision of such education as an integral part of adequate exercise programming
After the intervention period of 12 weeks we follow the patients until 36 weeks In this follow-up period also two sub studies take place
1 Sensor-based guidance sub study only control patients from Cologne
2 Live-remote physical fitness and function testing in all control patients all sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None