cancer neoplasma Cancer
Conditions
Interventions
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 participant*s 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. If the participant cannot use the LION app or if the app is not accessible, the content of the app will be provided in another format. In addition to exercise, t
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.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must be: o >= 18 years of age o Diagnosed with any type of invasive or hematological cancer and completed their primary cancer treatment. 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. o Have received systemic chemotherapy (or a stem cell transplantation in case of a hematological malignancy) as part of their primary cancer treatment with curative intent (or remission, without active disease and no expected active treatment within 1 year in case of hematological malignancies). o No evidence of distant metastatic disease (in case of solid tumors; i.e., no diagnosis of metastatic disease in the regular clinical trajectory) o ECOG (Eastern Cooperative Oncology Group) performance status <= 2 o 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. o Access to good quality and stable internet connection to access the live-remote training sessions. o Able and willing to perform the exercise program and wear the activity tracker at least one week after T0 and around T2, T4, and T5 measurements and during training and online assessment sessions. o Able to read, speak and understand Dutch (for the other countries: their main language) o Ability to give consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: o Too physically active (i.e., >150 minutes/week of self-reported moderate-to-vigorous intensity leisure and sports activities; this threshold has also been used in other exercise RCTs and fits activity levels of all participating countries)or participation in an exercise program comparable to the LION exercise program. o Participants with a history of chemotherapy for a previous cancer diagnosis if treatment was received within the past 5 years, or if they are currently experiencing ongoing side effects from previous chemotherapy regardless of when it was administered. o Unstable on psychotropic medication o Participated in structured exercise intervention comparable to the LION exercise program during cancer treatment. o Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including: o Severe neurologic or cardiac impairment according to ACSM criteria o Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise o Uncontrolled pain o Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the treating physician o More than 1 week not able to attend training sessions during the LION intervention period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the LION RCT assessed at 12 weeks follow-up are: - HRQOL: Summary score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - A standardized symptom score per participant, based on their main side-effect defined at baseline: o Physical fatigue (EORTC QLQ-FA12) o Physical function (modified from EORTC QLQ-C30 physical function scale, i.e., the five QLQ-C30 physical function items and five items from the EORTC item bank that assess higher levels of physical functioning), anxiety and/or depressive symptoms (PHQ-ADS (Sum score PHQ-9 and GAD-7)), CIPN (EORTC QLQ-CIPN20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are defined as: * Additional Patient Reported Outcome Measures (PROMs): o Other HRQOL domains of the EORTC QLQ-C30 (including physical functioning), except for the summary score. o Fatigue (EORTC QLQ-FA12) o Anxiety and/or depressive symptoms (PHQ-ADS) o CIPN (EORTC QLQ-CIPN20 and 2 items of PRO-CTCAE) o Sleep problems (PSQI) o Pain (selected items from EORTC QLQ-SURV100) o Cognitive problems (2 subscales from FACT-Cog) o Work limitations (WLQ) o Body image (BIS) o Fear of recurrence (selected items from EORTC QLQ-SURV100) o Habitual physical activity (Modified Godin) * Physical fitness/performance/activity: o Aerobic capacity (Maximal Short Exercise Capacity with the Steep Ramp Test & Chester Step Test) o Muscle strength: Upper body muscle strength (hand grip strength, hypothetical 1 repetition maximum (h1-RM)- chest press) and lower body muscle strength (h1-RM leg press & 30 sec sit-to-stand test) o Physical function (Timed Up & Go (TUG) test) o Balance (Single Leg Stance test with open & closed eyes) o Physical activity (activity tracker) * Vital signs and anthropometrics o Blood pressure o Resting heart rate o Anthropometrics * Exercise-related biomarkers and blood cell counts * Cost-effectiveness: o Quality-Adjusted Life Years (QALYs) (EQ-5D-5L) o Healthcare, patient and family costs (modified iMCQ) o Productivity losses (modified iPCQ) Safety endpoints: - Exercise-related (serious) adverse events | — |
Countries
Australia, Germany, Netherlands, Portugal, Spain, Sweden
Contacts
Public ContactDavid Binyam
Universitair Medisch Centrum Utrecht
Outcome results
None listed