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