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.…
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Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Many cancer patients suffer from long-term treatment-related side-effects like
fatigue, low physical functioning, anxiety and/or 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 (e.g., 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.
Study 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 and/or
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 (i.e., exercise modules
based on participants* main side-effect) in a wide variety of cancer survivors.
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 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. 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.
Study burden and risks
Burden
- Burden of the study comprises time-investment, i.e., 2-3 visits to the study
center for measurements, completion of questionnaires at home (this takes
approximately 20-45 minutes) , participation in a live-remote exercise program
involving three hours of supervised exercise per week for 12 weeks.
Additionally, participants will be asked to wear an activity tracker (Fitbit)
during the study if feasible but at least one week after visit T0 and before
visit T2, T4 and T5, during the training and online assessment sessions.
Risks
* As with any exercise, injuries can occur; to minimize the risk, the exercise
program will be (live-remotely) supervised by a qualified exercise specialist.
To ensure safety and optimal execution of the exercises, health issues or
physical limitations that may hinder adherence to the standard exercise plan
will be identified during the visit at the study center and communicated to the
exercise trainer. In addition, a one-on-one intake session will be conducted
live-remotely. The goal of this session is to check the technical connection,
assess the safety of the participant's home exercise environment, and go
through the exercises. The exercise trainer will have the home address and an
emergency contact for all participants.
* Following blood draws, a hematoma can occur.
* Incidental findings can arise during the different measurements (e.g., blood
pressure measurement; assessment of depression and fresh blood analyses), which
will be reported to participants and their treating physician when potentially
clinically relevant.
Benefit
We expect that the exercise program will have a beneficial effect on the
participants* health status.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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)
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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85029.041.23 |