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)

Anouk E Hiensch; Jana Müller; Eva M Zopf; Martina E Schmidt; Evelyn M Monninkhof; Mark Trevaskis; Jon Belloso; Dorothea Clauss; Nadira Gunasekara; Ana Joaquim; Sofia Viamonte; Moritz Schumann; Lars Heinrich; Alina Kias; David Binyam; Lonneke van de Poll; Laurien M Buffart; Neil K Aaronson; Elsken van der Wall; Anna Campbell; Joachim Wiskemann; Helene Rundqvist; Alberto J Alves; Ander Urruticoechea; Wilhelm Bloch; Martijn M Stuiver; Yvonne Wengström; Karen Steindorf; Anne M May

doi:10.1186/s13063-025-09263-1

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)

Anouk E Hiensch
, Jana Müller
, Eva M Zopf
, Martina E Schmidt
, Evelyn M Monninkhof
, Mark Trevaskis
, Jon Belloso
, Dorothea Clauss
, Nadira Gunasekara
, Ana Joaquim
, Sofia Viamonte
, Moritz Schumann
, Lars Heinrich
, Alina Kias
, David Binyam
, Lonneke van de Poll
, Laurien M Buffart
, Neil K Aaronson
, Elsken van der Wall
, Anna Campbell

Joachim Wiskemann, Helene Rundqvist, Alberto J Alves, Ander Urruticoechea, Wilhelm Bloch, Martijn M Stuiver, Yvonne Wengström, Karen Steindorf, Anne M May^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Exercise is an effective strategy to reduce cancer- and treatment-related side effects and improve quality of life (QoL). Larger exercise effects are observed in cancer survivors with a higher symptom burden and when exercise interventions are supervised. Most studies conducted to date have not screened for symptoms at baseline and tailored the exercise intervention accordingly. Additionally, time and travel distance are common barriers to participation in supervised in-person exercise programs. Live-remote exercise, where exercise sessions are supervised by an exercise professional via a videoconferencing platform, might help overcome these barriers. Here, we describe the design of the LION randomized controlled trial (RCT). This RCT aims to assess the (cost-)effectiveness of side effect-targeted, live-remote exercise on QoL and the participants' most burdensome side effect-fatigue, emotional distress, low physical functioning, or chemotherapy-induced peripheral neuropathy (CIPN)-in individuals who have completed primary curative cancer treatment.

METHODS: The LION study is a multinational RCT that will enroll 352 individuals who have completed primary curative cancer treatment including chemotherapy, within the previous 12-52 weeks and screen positive for ≥ 1 of the targeted side effects. Participants are randomly allocated (1:1) to the intervention or wait list control group. Participants in the intervention group receive a 12-week supervised exercise program consisting of three live-remote exercise sessions per week. Each participant receives the same base module (2×/week) and one specific module (1×/week) targeting their most burdensome side effect. Wait list control participants receive the same exercise program 12 weeks post-baseline. The primary outcomes are HRQoL (EORTC QLQ-C30 summary score) and a standardized symptom score based on each participant's most burdensome side effect (physical fatigue: EORTC QLQ-FA12, emotional distress: PHQ-ADS, physical functioning: EORTC QLQ-C30 modified physical functioning scale, CIPN: EORTC QLQ-CIPN20), assessed at baseline, 6, 12 (primary time point), 18 (wait list control group only), 24 and 36 weeks post-baseline.

DISCUSSION: This RCT will provide evidence regarding the (cost-)effectiveness of side effect-targeted, live-remote exercise in individuals experiencing side effects following primary curative cancer treatment. If proven (cost-)effective, live-remote exercise could be offered to individuals as part of standard follow-up cancer care to extend the reach of exercise support.

TRIAL REGISTRATION: NCT06270628. Registered on February 13, 2024.

Original language	English
Article number	540
Number of pages	16
Journal	Trials
Volume	26
Issue number	1
DOIs	https://doi.org/10.1186/s13063-025-09263-1
Publication status	Published - 24 Nov 2025

Keywords

Antineoplastic Agents/adverse effects
Cancer Survivors/psychology
Cost-Benefit Analysis
Exercise Therapy/methods
Female
Humans
Male
Multicenter Studies as Topic
Neoplasms/therapy
Psychological Distress
Quality of Life
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
Videoconferencing

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10.1186/s13063-025-09263-1Licence: CC BY

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)Final published version, 1.92 MBLicence: CC BY

Cite this

Hiensch, A. E., Müller, J., Zopf, E. M., Schmidt, M. E., Monninkhof, E. M., 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, L. M., Aaronson, N. K., van der Wall, E., ... May, A. M. (2025). 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, 26(1), Article 540. https://doi.org/10.1186/s13063-025-09263-1

@article{83c72c4f67f946ca94ce2c45b9bea763,

title = "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)",

abstract = "BACKGROUND: Exercise is an effective strategy to reduce cancer- and treatment-related side effects and improve quality of life (QoL). Larger exercise effects are observed in cancer survivors with a higher symptom burden and when exercise interventions are supervised. Most studies conducted to date have not screened for symptoms at baseline and tailored the exercise intervention accordingly. Additionally, time and travel distance are common barriers to participation in supervised in-person exercise programs. Live-remote exercise, where exercise sessions are supervised by an exercise professional via a videoconferencing platform, might help overcome these barriers. Here, we describe the design of the LION randomized controlled trial (RCT). This RCT aims to assess the (cost-)effectiveness of side effect-targeted, live-remote exercise on QoL and the participants' most burdensome side effect-fatigue, emotional distress, low physical functioning, or chemotherapy-induced peripheral neuropathy (CIPN)-in individuals who have completed primary curative cancer treatment.METHODS: The LION study is a multinational RCT that will enroll 352 individuals who have completed primary curative cancer treatment including chemotherapy, within the previous 12-52 weeks and screen positive for ≥ 1 of the targeted side effects. Participants are randomly allocated (1:1) to the intervention or wait list control group. Participants in the intervention group receive a 12-week supervised exercise program consisting of three live-remote exercise sessions per week. Each participant receives the same base module (2{\texttimes}/week) and one specific module (1{\texttimes}/week) targeting their most burdensome side effect. Wait list control participants receive the same exercise program 12 weeks post-baseline. The primary outcomes are HRQoL (EORTC QLQ-C30 summary score) and a standardized symptom score based on each participant's most burdensome side effect (physical fatigue: EORTC QLQ-FA12, emotional distress: PHQ-ADS, physical functioning: EORTC QLQ-C30 modified physical functioning scale, CIPN: EORTC QLQ-CIPN20), assessed at baseline, 6, 12 (primary time point), 18 (wait list control group only), 24 and 36 weeks post-baseline.DISCUSSION: This RCT will provide evidence regarding the (cost-)effectiveness of side effect-targeted, live-remote exercise in individuals experiencing side effects following primary curative cancer treatment. If proven (cost-)effective, live-remote exercise could be offered to individuals as part of standard follow-up cancer care to extend the reach of exercise support.TRIAL REGISTRATION: NCT06270628. Registered on February 13, 2024.",

keywords = "Antineoplastic Agents/adverse effects, Cancer Survivors/psychology, Cost-Benefit Analysis, Exercise Therapy/methods, Female, Humans, Male, Multicenter Studies as Topic, Neoplasms/therapy, Psychological Distress, Quality of Life, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, Videoconferencing",

author = "Hiensch, \{Anouk E\} and Jana M{\"u}ller and Zopf, \{Eva M\} and Schmidt, \{Martina E\} and Monninkhof, \{Evelyn M\} and Mark Trevaskis and Jon Belloso and Dorothea Clauss and Nadira Gunasekara and Ana Joaquim and Sofia Viamonte and Moritz Schumann and Lars Heinrich and Alina Kias and David Binyam and \{van de Poll\}, Lonneke and Buffart, \{Laurien M\} and Aaronson, \{Neil K\} and \{van der Wall\}, Elsken and Anna Campbell and Joachim Wiskemann and Helene Rundqvist and Alves, \{Alberto J\} and Ander Urruticoechea and Wilhelm Bloch and Stuiver, \{Martijn M\} and Yvonne Wengstr{\"o}m and Karen Steindorf and May, \{Anne M\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = nov,

day = "24",

doi = "10.1186/s13063-025-09263-1",

language = "English",

volume = "26",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

Hiensch, AE, Müller, 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, Wengström, Y, Steindorf, K & May, AM 2025, '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, vol. 26, no. 1, 540. https://doi.org/10.1186/s13063-025-09263-1

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). / Hiensch, Anouk E; Müller, Jana; Zopf, Eva M et al.
In: Trials, Vol. 26, No. 1, 540, 24.11.2025.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Effects of personalized live-remote exercise for individuals living beyond primary curative cancer treatment

T2 - study protocol for a multinational, super umbrella randomized controlled trial (LION-RCT)

AU - Hiensch, Anouk E

AU - Müller, Jana

AU - Zopf, Eva M

AU - Schmidt, Martina E

AU - Monninkhof, Evelyn M

AU - Trevaskis, Mark

AU - Belloso, Jon

AU - Clauss, Dorothea

AU - Gunasekara, Nadira

AU - Joaquim, Ana

AU - Viamonte, Sofia

AU - Schumann, Moritz

AU - Heinrich, Lars

AU - Kias, Alina

AU - Binyam, David

AU - van de Poll, Lonneke

AU - Buffart, Laurien M

AU - Aaronson, Neil K

AU - van der Wall, Elsken

AU - Campbell, Anna

AU - Wiskemann, Joachim

AU - Rundqvist, Helene

AU - Alves, Alberto J

AU - Urruticoechea, Ander

AU - Bloch, Wilhelm

AU - Stuiver, Martijn M

AU - Wengström, Yvonne

AU - Steindorf, Karen

AU - May, Anne M

PY - 2025/11/24

Y1 - 2025/11/24

N2 - BACKGROUND: Exercise is an effective strategy to reduce cancer- and treatment-related side effects and improve quality of life (QoL). Larger exercise effects are observed in cancer survivors with a higher symptom burden and when exercise interventions are supervised. Most studies conducted to date have not screened for symptoms at baseline and tailored the exercise intervention accordingly. Additionally, time and travel distance are common barriers to participation in supervised in-person exercise programs. Live-remote exercise, where exercise sessions are supervised by an exercise professional via a videoconferencing platform, might help overcome these barriers. Here, we describe the design of the LION randomized controlled trial (RCT). This RCT aims to assess the (cost-)effectiveness of side effect-targeted, live-remote exercise on QoL and the participants' most burdensome side effect-fatigue, emotional distress, low physical functioning, or chemotherapy-induced peripheral neuropathy (CIPN)-in individuals who have completed primary curative cancer treatment.METHODS: The LION study is a multinational RCT that will enroll 352 individuals who have completed primary curative cancer treatment including chemotherapy, within the previous 12-52 weeks and screen positive for ≥ 1 of the targeted side effects. Participants are randomly allocated (1:1) to the intervention or wait list control group. Participants in the intervention group receive a 12-week supervised exercise program consisting of three live-remote exercise sessions per week. Each participant receives the same base module (2×/week) and one specific module (1×/week) targeting their most burdensome side effect. Wait list control participants receive the same exercise program 12 weeks post-baseline. The primary outcomes are HRQoL (EORTC QLQ-C30 summary score) and a standardized symptom score based on each participant's most burdensome side effect (physical fatigue: EORTC QLQ-FA12, emotional distress: PHQ-ADS, physical functioning: EORTC QLQ-C30 modified physical functioning scale, CIPN: EORTC QLQ-CIPN20), assessed at baseline, 6, 12 (primary time point), 18 (wait list control group only), 24 and 36 weeks post-baseline.DISCUSSION: This RCT will provide evidence regarding the (cost-)effectiveness of side effect-targeted, live-remote exercise in individuals experiencing side effects following primary curative cancer treatment. If proven (cost-)effective, live-remote exercise could be offered to individuals as part of standard follow-up cancer care to extend the reach of exercise support.TRIAL REGISTRATION: NCT06270628. Registered on February 13, 2024.

AB - BACKGROUND: Exercise is an effective strategy to reduce cancer- and treatment-related side effects and improve quality of life (QoL). Larger exercise effects are observed in cancer survivors with a higher symptom burden and when exercise interventions are supervised. Most studies conducted to date have not screened for symptoms at baseline and tailored the exercise intervention accordingly. Additionally, time and travel distance are common barriers to participation in supervised in-person exercise programs. Live-remote exercise, where exercise sessions are supervised by an exercise professional via a videoconferencing platform, might help overcome these barriers. Here, we describe the design of the LION randomized controlled trial (RCT). This RCT aims to assess the (cost-)effectiveness of side effect-targeted, live-remote exercise on QoL and the participants' most burdensome side effect-fatigue, emotional distress, low physical functioning, or chemotherapy-induced peripheral neuropathy (CIPN)-in individuals who have completed primary curative cancer treatment.METHODS: The LION study is a multinational RCT that will enroll 352 individuals who have completed primary curative cancer treatment including chemotherapy, within the previous 12-52 weeks and screen positive for ≥ 1 of the targeted side effects. Participants are randomly allocated (1:1) to the intervention or wait list control group. Participants in the intervention group receive a 12-week supervised exercise program consisting of three live-remote exercise sessions per week. Each participant receives the same base module (2×/week) and one specific module (1×/week) targeting their most burdensome side effect. Wait list control participants receive the same exercise program 12 weeks post-baseline. The primary outcomes are HRQoL (EORTC QLQ-C30 summary score) and a standardized symptom score based on each participant's most burdensome side effect (physical fatigue: EORTC QLQ-FA12, emotional distress: PHQ-ADS, physical functioning: EORTC QLQ-C30 modified physical functioning scale, CIPN: EORTC QLQ-CIPN20), assessed at baseline, 6, 12 (primary time point), 18 (wait list control group only), 24 and 36 weeks post-baseline.DISCUSSION: This RCT will provide evidence regarding the (cost-)effectiveness of side effect-targeted, live-remote exercise in individuals experiencing side effects following primary curative cancer treatment. If proven (cost-)effective, live-remote exercise could be offered to individuals as part of standard follow-up cancer care to extend the reach of exercise support.TRIAL REGISTRATION: NCT06270628. Registered on February 13, 2024.

KW - Antineoplastic Agents/adverse effects

KW - Cancer Survivors/psychology

KW - Cost-Benefit Analysis

KW - Exercise Therapy/methods

KW - Female

KW - Humans

KW - Male

KW - Multicenter Studies as Topic

KW - Neoplasms/therapy

KW - Psychological Distress

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Time Factors

KW - Treatment Outcome

KW - Videoconferencing

U2 - 10.1186/s13063-025-09263-1

DO - 10.1186/s13063-025-09263-1

M3 - Article

C2 - 41287048

SN - 1745-6215

VL - 26

JO - Trials

JF - Trials

IS - 1

M1 - 540

ER -

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)

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Keywords

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