Clinical trial NCT06270628: Personalized Live-remote Exercise Training for Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: cancer survivors
exercise
live remote
personalized exercise training
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: German Sport University Cologne (DSHS), Cologne, Germany
name: Cabrini Health (CAB), Malvern, Australia
name: Karolinska Institute (KI), Stockholm, Sweden
name: Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands
name: Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany
name: Fundacion Onkologikao (ONK), San Sebastian, Spain
name: Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal
First posted: 2024-02-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with two study arms: exercise group and wait list control group
Primary purpose: SUPPORTIVE_CARE

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 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)

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

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: Week 0 - Week 12
measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
timeFrame: Week 0 - Week 12
measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
timeFrame: Week 0 - Week 12
measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
timeFrame: Week 0 - Week 12
measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
timeFrame: Week 0 - Week 12
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Week 0 - Week 36
measure: Fatigue
timeFrame: Week 0 - Week 36
measure: Anxiety and Depression
timeFrame: Week 0 - Week 36
measure: CIPN_1
timeFrame: Week 0 - Week 36
measure: CIPN_2
timeFrame: Week 0 - Week 36
measure: Sleep
timeFrame: 0-36 weeks
measure: Pain prevalence and type
timeFrame: Week 0 - Week 36
measure: Cognitive problems
timeFrame: Week 0 - Week 36
measure: Work limitations
timeFrame: Week 0 - Week 36
measure: Body image
timeFrame: Week 0 - Week 36
measure: Fear of cancer recurrence
timeFrame: 0-36 weeks
measure: Habitual physical activity
timeFrame: Week 0 - Week 36
measure: Aerobic capacity on bike
timeFrame: Week 0 - Week 24
measure: Aerobic capacity on step
timeFrame: Week 0 - Week 24
measure: Handgrip strength
timeFrame: Week 0 - Week 24
measure: Upper body muscle strength
timeFrame: Week 0 - Week 24
measure: Lower body muscle strength
timeFrame: 0-24 weeks
measure: Sit to stand test
timeFrame: Week 0 - Week 24
measure: Physical function
timeFrame: Week 0 - Week 24
measure: Balance
timeFrame: Week 0 - Week 24
measure: Physical activity
timeFrame: 0-36 weeks
measure: Blood pressure
timeFrame: 0-24 weeks
measure: Resting heart rate
timeFrame: Week 0 - Week 24
measure: Weight
timeFrame: Week 0 - Week 24
measure: Height
timeFrame: Week 0 - Week 24
measure: Waist circumference
timeFrame: Week 0 - Week 24
measure: Hip circumference
timeFrame: Week 0 - Week 24
measure: Body composition
timeFrame: Week 0 - Week 24
measure: Inflammatory state
timeFrame: 0-12 weeks
measure: Growth factors
timeFrame: 0-12 weeks
measure: CRP
timeFrame: Week 0 - Week 12
measure: Hemoglobin
timeFrame: 0-12 weeks
measure: Leucocyte counts
timeFrame: 0-12 weeks
measure: Quality-adjusted life years
timeFrame: Week 0 - Week 36
measure: Health-care, patient and family costs
timeFrame: Week 0 - Week 36
measure: Productivity losses
timeFrame: Week 0 - Week 36
measure: Exercise-related (serious) adverse events
timeFrame: Week 0 - Week 36
Other outcomes:
measure: Participants experience of sensor-based guidance
timeFrame: Week 12- Week 24
measure: Trainer experience of sensor-based guidance
timeFrame: Week 12- Week 24
measure: Compliance sensor-based guidance
timeFrame: Week 12- Week 24
measure: Technical feasibility of sensor-based guidance
timeFrame: Week 12- Week 24
measure: Aerobic capacity
timeFrame: Week 12- Week 24
measure: Upper body muscle strength
timeFrame: Week 12- Week 24
measure: Lower body muscle strength
timeFrame: Week 12- Week 24
measure: Core muscle strength
timeFrame: Week 12- Week 24
measure: Physical functioning
timeFrame: Week 12- Week 24
measure: Balance
timeFrame: Week 12- Week 24
measure: Socio-demographics
timeFrame: baseline
measure: Self-efficacy
timeFrame: baseline
measure: Social Support
timeFrame: baseline
measure: Medical history
timeFrame: baseline
measure: Concomitant diseases
timeFrame: Week 0- Week 36
measure: Cancer + concomitant medication
timeFrame: Week 0- Week 36
measure: Cancer characteristics
timeFrame: baseline
measure: Cancer treatment history
timeFrame: baseline
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References: