Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06270628

Personalized Live-remote Exercise Training for Cancer Survivors

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-02-14

Completion Date

2027-10-31

Last Updated

2025-04-15

Healthy Volunteers

Conditions

Neoplasms

Interventions

BEHAVIORAL

Exercise group

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

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

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands