Personalized Live-remote Exercise Training for Cancer Survivors

NCT06270628 | Recruiting

• 1 other identifier: NL85029.018.23
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

cancer survivors; exercise; live remote; personalized exercise training

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (37)

• Health-related quality of life

  Week 0 - Week 36

• Fatigue

  Week 0 - Week 36

• Anxiety and Depression

  Week 0 - Week 36

• CIPN_1

  Week 0 - Week 36

• CIPN_2

  Week 0 - Week 36

Other Outcomes (18)

• Participants experience of sensor-based guidance

  Week 12- Week 24

• Trainer experience of sensor-based guidance

  Week 12- Week 24

• Compliance sensor-based guidance

  Week 12- Week 24

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants will be offered three live-remote exercise training sessions per week. Each participant in the trial will be provided with the base module twice a week, which will involve a personalized training intensity. This module aims at targeting the participants' HRQOL, which is the first primary endpoint of the trial. Additionally, each participant will receive one out of four specific modules once a week to address their individual main side-effect (based on shared decision-making (SDM)) (second primary outcome). The intervention also includes an educational component about exercise and cancer.

Behavioral: Exercise group

Wait list control group

NO INTERVENTION

Regular care The control group will receive the same exercise program after the 12 weeks intervention period

Interventions

Exercise group BEHAVIORAL

Live-remote exercise sessions, personalized to the patients main side-effect

Exercise group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, a subject must be:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• Hiensch AE, Muller J, Zopf EM, Schmidt ME, Monninkhof EM, Trevaskis M, Belloso J, Clauss D, Gunasekara N, Joaquim A, Viamonte S, Schumann M, Heinrich L, Kias A, Binyam D, van de Poll L, Buffart LM, Aaronson NK, van der Wall E, Campbell A, Wiskemann J, Rundqvist H, Alves AJ, Urruticoechea A, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, May AM. Effects of personalized live-remote exercise for individuals living beyond primary curative cancer treatment: study protocol for a multinational, super umbrella randomized controlled trial (LION-RCT). Trials. 2025 Nov 24;26(1):540. doi: 10.1186/s13063-025-09263-1.

  PMID: 41287048 DERIVED

Related Links

• study website

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Evelyn Monninkhof, PhD

CONTACT

+3161118187; e.monninkhof@umcutrecht.nl

Anne May, PhD

CONTACT

+3161118187; a.m.may@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: RCT with two study arms: exercise group and wait list control group

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 21, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the study analyses by the study team (TBD).
• Access Criteria: TBD in the DMP.

Locations

NL (1)