A new multinational study, the LION trial, is investigating the effectiveness of a personalized, live-remote exercise program in improving the health-related quality of life (HRQoL) and reducing burdensome side effects for individuals who have completed primary cancer treatment. This randomized controlled trial (RCT), registered with ClinicalTrials.gov (NCT06270628) and approved by institutional review boards in participating countries, aims to provide an evidence-based exercise intervention for cancer survivors.
The LION study involves 352 participants recruited from eight hospitals and study centers across five European countries and Australia. Participants are enrolled between 12 and 52 weeks after completing primary cancer treatment, encompassing various cancer diagnoses. Eligibility criteria are rigorously checked by physicians at the treating hospitals, and informed consent is obtained from all participants. The first participant was enrolled on February 14, 2024.
Study Design and Intervention
The study divides participants into two groups: an intervention group that receives a 12-week personalized, live-remote exercise program, and a waitlist control group that receives the same program after a 12-week control period. Both groups continue their usual care throughout the study. The primary hypothesis is that the exercise program will improve HRQoL and/or reduce participants’ most bothersome side effects within 12 weeks compared to the control group.
The core of the intervention is a 12-week live-remote multimodal exercise program delivered via Zoom, with three sessions per week. Each session, lasting 60–75 minutes, is supervised by a qualified exercise professional and involves a maximum of 10 participants. The program employs a modularized approach, with two weekly sessions focused on improving HRQoL (Base Module) and one session specifically targeting the participant’s most burdensome side effect (Specific Module). Participants receive an exercise kit including a gym mat, dumbbells, resistance bands, and an aerobic stepper, along with an activity tracker (Fitbit) to monitor their physical activity.
The Base Module adheres to the American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors, incorporating warm-up, resistance training targeting major muscle groups, and aerobic training. The Specific Modules are tailored to address common post-cancer treatment side effects:
- Fatigue: Sessions include breathing exercises, joint mobilization, and mind-body exercises (yoga and Tai Chi-based) focusing on body awareness and relaxation.
- Emotional Distress: This module features breathing exercises, joint mobilization, and yoga-based exercises, concluding with audio-guided relaxation.
- Low Physical Functioning: Participants in this group receive a third weekly Base Module session, aligning with ACSM guidelines.
- Chemotherapy-Induced Peripheral Neuropathy (CIPN): The module focuses on sensorimotor and balance exercises, hand training, and agility training, utilizing additional equipment like a foam pad and massage balls.
Participants also receive an educational component delivered via an app and printouts. These resources aim to improve exercise adherence, enhance understanding of side effects, promote behavioral change, and support a physically active lifestyle post-intervention. For the waitlist control group, the exercise kit and program are provided after the initial 12-week monitoring period.
Outcomes and Assessment
The LION trial focuses on two primary outcomes: HRQoL, measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 summary score, and the participant’s most burdensome side effect. Specific validated questionnaires are used for each side effect: the EORTC QLQ-FA12 for physical fatigue, the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) for emotional distress, the EORTC QLQ-C30 physical functioning scale (extended with items from the item bank) for low physical functioning, and the EORTC QLQ-CIPN20 for CIPN. These outcomes are assessed at baseline, 12 weeks, and 24 weeks, with additional remote assessments at 6, 18, and 36 weeks. The study design also includes a cost-effectiveness analysis to compare the intervention’s costs and health effects using quality-adjusted life years (QALYs), aligning with efforts to optimize healthcare resource allocation [thelancet.com].
Public Health Relevance
Antimicrobial resistance (AMR) is a significant global health threat, influencing the effectiveness of treatments, as highlighted in the latest global antibiotic resistance surveillance report, which analyzed over 23 million bacteriologically confirmed cases of infections [who.int]. The focus of the LION study on improving HRQoL and managing common side effects after cancer treatment is crucial in addressing comprehensive patient care. As the World Health Organization (WHO) has identified the urgent need for new vaccines targeting endemic pathogens like HIV, malaria, and tuberculosis, which together cause nearly 2.5 million deaths annually, improving supportive care for survivors of other diseases like cancer is also vital for public health [who.int]. Additionally, public health initiatives such as the 2026 High-level Meeting on Pandemic Prevention, Preparedness, and Response underscore the ongoing global commitment to health infrastructure improvements [theindependentpanel.org]. Research into effective post-treatment interventions like personalized exercise programs contributes to a more resilient and healthier population in the face of evolving global health challenges.
Read more on Globally Pulse Health for additional insights into emerging health trends and research.
