Personalized Live-remote Exercise Training for Cancer Survivors

Neoplasms Clinical Trial

— LION  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06270628
• Other study ID #: NL85029.018.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: Evelyn Monninkhof, PhD
• Phone: +3161118187
• Email: e.monninkhof[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Exercise group
Live-remote exercise sessions, personalized to the patients main side-effect

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (9)

Lead Sponsor

Collaborator

UMC Utrecht

Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal, Cabrini Health (CAB), Malvern, Australia, Fundacion Onkologikao (ONK), San Sebastian, Spain, German Cancer Research Center (DKFZ), Heidelberg, Germany, German Sport University Cologne (DSHS), Cologne, Germany, Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany, Karolinska Institute (KI), Stockholm, Sweden, Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants experience of sensor-based guidance	Questionnaires - substudy control patients Cologne	Week 12- Week 24
Other	Trainer experience of sensor-based guidance	Questionnaires - substudy control patients Cologne	Week 12- Week 24
Other	Compliance sensor-based guidance	% of sessions that patients wear the sensor - substudy control patients Cologne	Week 12- Week 24
Other	Technical feasibility of sensor-based guidance	% of successful live transfer of sensor data - substudy control patients Cologne	Week 12- Week 24
Other	Aerobic capacity	Chester Step test - substudy live-remote testing	Week 12- Week 24
Other	Upper body muscle strength	Push-up test - substudy live-remote testing	Week 12- Week 24
Other	Lower body muscle strength	30 sec sit-to stand test - substudy live-remote testing	Week 12- Week 24
Other	Core muscle strength	Plank position holding time - substudy live-remote testing	Week 12- Week 24
Other	Physical functioning	Time Up and Go (TUG) test - substudy live-remote testing	Week 12- Week 24
Other	Balance	Single leg stance test with open and closed eyes - substudy live-remote testing	Week 12- Week 24
Other	Socio-demographics	Self-designed questionnaire	baseline
Other	Self-efficacy	General Self-Efficacy Scale	baseline
Other	Social Support	Index of Sojourner Social Support (ISSS)	baseline
Other	Medical history	Interview	baseline
Other	Concomitant diseases	Interview	Week 0- Week 36
Other	Cancer + concomitant medication	Interview	Week 0- Week 36
Other	Cancer characteristics	Interview	baseline
Other	Cancer treatment history	Interview	baseline
Primary	Health-Related Quality of Life	Measured with the summary scale of the EORTC QLQ-C30; min 0- max 100 points; higher scores mean better quality of life	Week 0 - Week 12
Primary	A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline	Side-effect 1: Fatigue measured with EORTC QLQ-FA12. According to a standardization procedure the symptom score of all patients will be combined into one symptom score..	Week 0 - Week 12
Primary	A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline	Side-effect 2: Anxiety and depressive symptoms measured with Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). According to a standardization procedure the symptom score of all patients will be combined into one symptom score.	Week 0 - Week 12
Primary	A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline	Side-effect 3: Physical functioning measured with EORTC QLQ-C30 physical function scale According to a standardization procedure the symptom score of all patients will be combined into one symptom score.	Week 0 - Week 12
Primary	A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline	Side-effect 4: CPIN measured with EORTC QLQ-CPIN20. According to a standardization procedure the symptom score of all patients will be combined into one symptom score.	Week 0 - Week 12
Secondary	Health-related quality of life	Domains of the EORTC QLQ-C30 (except summary score)	Week 0 - Week 36
Secondary	Fatigue	Cancer-Related fatigue measured with the EORTC-FA12	Week 0 - Week 36
Secondary	Anxiety and Depression	Anxiety and depressive symptoms measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)	Week 0 - Week 36
Secondary	CIPN_1	Chemotherapy-induced peripheral neuropathy measured with EORTC QLQ-CIPN-20	Week 0 - Week 36
Secondary	CIPN_2	2 items of the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	Week 0 - Week 36
Secondary	Sleep	Pittsburgh Sleep Quality Index (PSQI)	0-36 weeks
Secondary	Pain	EORTC QLQ-SURV100	Week 0 - Week 36
Secondary	Cognitive problems	Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)	Week 0 - Week 36
Secondary	Work limitations	Work Limitations Questionnaire (WLQ)	Week 0 - Week 36
Secondary	Body image	Body Image Scale (BIS)	Week 0 - Week 36
Secondary	Fear of cancer recurrence	EORTC QLQ-surv100	0-36 weeks
Secondary	Habitual physical activity	Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire	Week 0 - Week 36
Secondary	Aerobic capacity on bike	Steep ramp test	Week 0 - Week 24
Secondary	Aerobic capacity on step	Chester step test	Week 0 - Week 24
Secondary	Handgrip strength	Handgrip test	Week 0 - Week 24
Secondary	Upper body muscle strength	Chest press	Week 0 - Week 24
Secondary	Lower body muscle strength	Leg press	0-24 weeks
Secondary	Sit to stand test	30 sec sit to stand test- function test	Week 0 - Week 24
Secondary	Physical function	Time Up and Go (TUG) test	Week 0 - Week 24
Secondary	Balance	Single leg stance test with open and closed eyes	Week 0 - Week 24
Secondary	Physical activity	Measured with an activity tracker (Fitbit)	0-36 weeks
Secondary	Blood pressure	Measured twice with blood pressure device	0-24 weeks
Secondary	Resting heart rate	Measured with blood pressure device	Week 0 - Week 24
Secondary	Weight	Weight. in KG	Week 0 - Week 24
Secondary	Height	Height in cm	Week 0 - Week 24
Secondary	Waist circumference	Waist circumference in cm	Week 0 - Week 24
Secondary	Hip circumference	Hip circumference in cm	Week 0 - Week 24
Secondary	Body composition	Fat mass and fat free mass with bio-impedance - three centers	Week 0 - Week 24
Secondary	Inflammatory state	The specific inflammatory markers (e.g., cytokines, interleukins) will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms; we will for example use the Olink PEA platform (Oncology and Inflammation Array)	0-12 weeks
Secondary	Growth factors	The specific growth factors will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms ; we will for example use the Olink PEA platform (Oncology and Inflammation Array)	0-12 weeks
Secondary	CRP	Blood cell count	Week 0 - Week 12
Secondary	Hemoglobin	Blood cell count	0-12 weeks
Secondary	Leucocyte counts	Blood cell count	0-12 weeks
Secondary	Quality-adjusted life years	EuroQol-5D-5L	Week 0 - Week 36
Secondary	Health-care, patient and family costs	Modified Medical Consumption Questionnaire (iMCQ)	Week 0 - Week 36
Secondary	Productivity losses	Modified Productivity Cost Questionnaire (iPCQ)	Week 0 - Week 36
Secondary	Exercise-related (serious) adverse events	Via CASTOR app before and after each session; asked at and at the study visits.	Week 0 - Week 36

External Links

•   study website