Trial Title:
Personalized Live-remote Exercise Training for Cancer Survivors
NCT ID:
NCT06270628
Condition:
Neoplasms
Conditions: Keywords:
cancer survivors
exercise
live remote
personalized exercise training
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RCT with two study arms: exercise group and wait list control group
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise group
Description:
Live-remote exercise sessions, personalized to the patients main side-effect
Arm group label:
Exercise group
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 and/or 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 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.
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 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.
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.
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 and/or depressive symptoms, CIPN. Additionally, participants need to
be relatively physically inactive, i.e., perform ≤210 minutes/week 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 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.
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)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
To be eligible to participate in this study, a subject must be:
- 18 years of age or older
- Diagnosed with any type of invasive cancer and have received systemic chemotherapy
as part of their primary cancer treatment
- Within the timeframe of 12 weeks to 1 year after the completion of their primary
cancer treatment with curative intent. 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.
- No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease
in the regular clinical trajectory)
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- 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.19-21
- Access to good quality and stable internet connection to access the live-remote
training sessions.
- Able and willing to perform the exercise program and wear the activity tracker at
least one week after T0 and before T2, T4, and T5 measurements and during training
and online assessment sessions.
- Able to read, speak and understand the main country language.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
- Too physically active (i.e., >210 minutes/week of self-reported moderate-to-vigorous
or leisure and sports activities; this threshold has also been used in other
exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all
participating countries) or participation in an exercise program comparable to the
LION exercise program.
- Following, or planned to follow, a structured psychological intervention during the
intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic
medication
- Participated in the intervention group of an exercise study during cancer treatment
- Inability to complete the testing or training sessions or any other
contraindications for exercise as determined by the treating physician, including:
- Severe neurologic or cardiac impairment according to ACSM criteria
- Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in
rest or during exercise
- Uncontrolled pain All these exclusion criteria are formulated to ensure safe
participation in the LION exercise program
- Any circumstances that would impede ability to give informed consent or adherence to
study requirements as determined by the treating physician
- More than 1 week not able to attend training sessions during the LION intervention
period
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Start date:
February 20, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
German Cancer Research Center
Agency class:
Other
Collaborator:
Agency:
German Sport University Cologne (DSHS), Cologne, Germany
Agency class:
Other
Collaborator:
Agency:
Cabrini Health (CAB), Malvern, Australia
Agency class:
Other
Collaborator:
Agency:
Karolinska Institute (KI), Stockholm, Sweden
Agency class:
Other
Collaborator:
Agency:
Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands
Agency class:
Other
Collaborator:
Agency:
Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany
Agency class:
Other
Collaborator:
Agency:
Fundacion Onkologikao (ONK), San Sebastian, Spain
Agency class:
Other
Collaborator:
Agency:
Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal
Agency class:
Other
Source:
UMC Utrecht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06270628
https://www.preferable2.eu
