Personalized Live-remote Exercise Training for Cancer Survivors

ConditionNeoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUMC Utrecht

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Severe neurologic or cardiac impairment according to ACSM criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise group

    Behavioral

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

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Exercise groupExperimental treatment 1 intervention
Group B: Wait list control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Week 0 - Week 12
2

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..

Time frame
Week 0 - Week 12
3

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.

Time frame
Week 0 - Week 12
4

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.

Time frame
Week 0 - Week 12

Secondary outcomes

1

Health-related quality of life

Domains of the EORTC QLQ-C30 (except summary score)

Time frame
Week 0 - Week 36
2

Fatigue

Cancer-Related fatigue measured with the EORTC-FA12

Time frame
Week 0 - Week 36
3

Anxiety and Depression

Anxiety and depressive symptoms measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Time frame
Week 0 - Week 36
4

CIPN_1

Chemotherapy-induced peripheral neuropathy measured with EORTC QLQ-CIPN-20

Time frame
Week 0 - Week 36

Other outcomes

1

Participants experience of sensor-based guidance

Questionnaires - substudy control patients Cologne

Time frame
Week 12- Week 24
2

Trainer experience of sensor-based guidance

Questionnaires - substudy control patients Cologne

Time frame
Week 12- Week 24
3

Compliance sensor-based guidance

% of sessions that patients wear the sensor - substudy control patients Cologne

Time frame
Week 12- Week 24
4

Technical feasibility of sensor-based guidance

% of successful live transfer of sensor data - substudy control patients Cologne

Time frame
Week 12- Week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UMC Utrecht

Lead sponsor

German Cancer Research Center

Collaborator

German Sport University, Cologne

Collaborator

Cabrini Health (CAB), Malvern, Australia

Collaborator

Karolinska Institute (KI), Stockholm, Sweden

Collaborator

The Netherlands Cancer Institute

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