Demonstrating the (cost-)effectiveness of a personalized live-remote exercise intervention for cancer survivors using a super umbrella randomized controlled trial: the LION-RCT
- Conditions
- cancer neoplasma10027656
- Registration Number
- NL-OMON56526
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
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)
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 Did receive chemotherapy as part of treatment for a previous diagnosis.
o Following or planned to follow a structural psychological intervention during
the intervention period, i.e., cognitive behavioral therapy, or 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints of the LION RCT assessed at 12 weeks follow-up are:<br /><br>- HRQOL: Summary score of the European Organization for Research and Treatment<br /><br>of Cancer (EORTC) QLQ-C30<br /><br>- A standardized symptom score per participant, based on their main side-effect<br /><br>defined at baseline:<br /><br>o Physical fatigue (EORTC QLQ-FA12)<br /><br>o Physical function (modified from EORTC QLQ-C30 physical function scale, i.e.,<br /><br>the five QLQ-C30 physical function items and five items from the EORTC item<br /><br>bank that assess higher levels of physical functioning), anxiety and/or<br /><br>depressive symptoms (PHQ-ADS (Sum score PHQ-9 and GAD-7)), CIPN (EORTC<br /><br>QLQ-CIPN20)</p><br>
- Secondary Outcome Measures
Name Time Method