FatigueYOUEXNCT05613699
Exercise for Young Adults With Cancer
A study testing Exercise - Social Media, Exercise - App and Exercise - closed to patients residence in people with Fatigue and Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Fatigue, Cancer, Physical Activity
- What is being tested?
- Exercise - Social Media, Exercise - App and Exercise - closed to patients residence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- cancer diagnosis within the past five years
- signed informed consent
Who cannot join
- cancer-related cognitive impairment
- lack of sports clearance from the attending oncologist (e.g. in case of fragile bone metastases)
- current participation in another exercise intervention
- insufficient German language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
National Center for Tumor Diseases
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer
Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.
- Conditions
- Fatigue, Cancer, Physical Activity, Exercise
- Being tested
- Exercise - Social Media, Exercise - App, Exercise - closed to patients residence
- Keywords
- cancer, social media, exercise, virtual training, app
- Medical subject headings
- Fatigue, Neoplasms, Motor Activity, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise - Social MediaBehavioural
The supervised online-social media exercise intervention took place once per week at a fixed, pre-scheduled time, via an online video conference platform. The training sessions lasted for 60 minutes and included a holistic workout with different focuses (e.g. resistance training for lower extremities, sensorimotor training, home-based endurance training). Patients were further recommended independent physical activity like walking or cycling, 1-2 times per week or to maintain the current volume of physical activity.
Exercise - AppBehavioural
Exercise program in the online-app were personalized and focused on a combination of endurance and resistance training, 2-3 times a week, depending on patient's needs. Additional types of exercise (e.g. sensorimotor training) were added if therapy-related side effects were present. If necessary, exercise trainers conducted one introductory training session as video conference to check for exercise techniques and answer any individual questions.
Exercise - closed to patients residenceBehavioural
The supervised exercise program close to patient's home was executed in a certified exercise facility of the network OnkoAktiv and supervised by special qualified exercise trainers. The weekly recommendation was to participate in a personalized in-person exercise program 1-2 per week, plus independent physical activity (or to maintain current level of physical activity)
| Study group | Role | What they receive |
|---|---|---|
| supervised, group-based, online-social media exercise program | Other | Not described Receives: Behavioral: Exercise - Social Media |
| unsupervised individual home-based training with an online-training app | Other | Not described Receives: Behavioral: Exercise - App |
| supervised, in-person exercise program close to place of residence | Other | Not described Receives: Behavioral: Exercise - closed to patients residence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the three exercise interventions
Participants ability to follow the exercise prescription (measured by % of training frequency as well as type of the exercise)
Measured: During 12 week of the intervention
Secondary outcomes (9)
Physical activity level
Physical activity levels were determined by the standardized Godin-Shephard Leisure-Time Questionnaire. The questionnaire was used to ask for pre-diagnosis-, post-diagnosis- and pre-post-intervention physical activity levels within three categories: light, moderate and vigorous physical activity in minutes per week. Participants were categorized in an active and inactive subgroup with a threshold of 150 minutes moderate or 75 minutes vigorous physical activity per week (or the combination of both) based on the American College of Sports Medicine (ACSM) guidelines.
Measured: 12 weeks and 24 weeks
Module Selection and preferences
The individual module selection and preferences were queried and documented at the first three time points (Baseline, after 6 week and after 12 weeks). Reasons for any module selection and why other modules have not been selected were collected through open answer questions while multiple answers were possible. The subgroups of the initial module selection were analyzed according treatment and employment status. Further, we asked for module preferences under COVID-19 free conditions
Measured: Baseline, 6 weeks, 12 weeks
Impact of COVID-19 pandemic
The questionnaire about the impact of COVID-19 has been self-developed, but internal validated in other studies at the National Center of Tumor Diseases (NCT) Heidelberg. The COVID-19 questionnaire consisted of six items and surveyed the impact of COVID-19 on patient´s current job situation, leisure-time activities, physical activity levels, self-efficacy, anxiety and mental health. Further we asked for, whether COVID-19 had any effect on the participants module selection. The COVID-19 questionnaire was submitted later during the ongoing study due to COVID-19-lockdown in November 2020. Therefore, not all participants completed the COVID-19 questionnaire
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Fatigue
Standardized questionnaire used: European Organisation for Research and Treatment of Cancer (EORTC) FA (Fatigue) 12
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Health-related quality of life
Quality of life (QoL) will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Distress
Standardized questionnaire used: National Comprehensive Cancer Network (NCCN) Distress-Thermometer
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Patient Satisfaction
Standardized questionnaire used: Zufriedenheit (ZUF)-8 Questionnaire
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Social Support
Standardized questionnaire used: German translation of the questionnaire by Sallis (1987)
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Fatigue Thermometer
Standardized questionnaire used: Style of NCCN Distress-Thermometer. Dimensions: Physical, emotional and mental Fatigue
Measured: Daily till week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Clinic Cologne, University Clinic Essen
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
- Investigators
- Joachim Wiskemann, PhD, Principal investigator, Heidelberg University Hospital / National Center for Tumor Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613699
- Sponsor's protocol ID
- YOUEX_S932
- Acronym
- YOUEX
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Voland A, Krell V, Gotte M, Niels T, Koppel M, Wiskemann J. Exercise Preferences in Young Adults with Cancer-The YOUEX Study. Curr Oncol. 2023 Jan 21;30(2):1473-1487. doi: 10.3390/curroncol30020113.
PubMed 36826074
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT05613699
- Acronym / sponsor ID
- YOUEX / YOUEX_S932
- Conditions
- Fatigue, Cancer, Physical Activity, Exercise
- Keywords
- cancer, social media, exercise, virtual training, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Clinic Cologne, University Clinic Essen
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| supervised, group-based, online-social media exercise program | Other | Behavioral: Exercise - Social Media |
| unsupervised individual home-based training with an online-training app | Other | Behavioral: Exercise - App |
| supervised, in-person exercise program close to place of residence | Other | Behavioral: Exercise - closed to patients residence |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- cancer diagnosis within the past five years
- signed informed consent
Key exclusion criteria (4 listed)
- cancer-related cognitive impairment
- lack of sports clearance from the attending oncologist (e.g. in case of fragile bone metastases)
- current participation in another exercise intervention
- insufficient German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise - Social MediaThe supervised online-social media exercise intervention took place once per week at a fixed, pre-scheduled time, via an online video conference platform. The training sessions lasted for 60 minutes and included a holistic workout with different focuses (e.g. resistance training for lower extremities, sensorimotor training, home-based endurance training). Patients were further recommended independent physical activity like walking or cycling, 1-2 times per week or to maintain the current volume of physical activity. | Behavioural | supervised, group-based, online-social media exercise program |
| Exercise - AppExercise program in the online-app were personalized and focused on a combination of endurance and resistance training, 2-3 times a week, depending on patient's needs. Additional types of exercise (e.g. sensorimotor training) were added if therapy-related side effects were present. If necessary, exercise trainers conducted one introductory training session as video conference to check for exercise techniques and answer any individual questions. | Behavioural | unsupervised individual home-based training with an online-training app |
| Exercise - closed to patients residenceThe supervised exercise program close to patient's home was executed in a certified exercise facility of the network OnkoAktiv and supervised by special qualified exercise trainers. The weekly recommendation was to participate in a personalized in-person exercise program 1-2 per week, plus independent physical activity (or to maintain current level of physical activity) | Behavioural | supervised, in-person exercise program close to place of residence |
Primary outcome
Feasibility of the three exercise interventions
Time frame: During 12 week of the intervention
Participants ability to follow the exercise prescription (measured by % of training frequency as well as type of the exercise)
9 secondary outcomes
Physical activity level
Time frame: 12 weeks and 24 weeks
Module Selection and preferences
Time frame: Baseline, 6 weeks, 12 weeks
Impact of COVID-19 pandemic
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Fatigue
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Health-related quality of life
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Distress
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Patient Satisfaction
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Social Support
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Fatigue Thermometer
Time frame: Daily till week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 36826074Voland A, Krell V, Gotte M, Niels T, Koppel M, Wiskemann J. Exercise Preferences in Young Adults with Cancer-The YOUEX Study. Curr Oncol. 2023 Jan 21;30(2):1473-1487. doi: 10.3390/curroncol30020113.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Wiskemann, PhD principal investigator
Heidelberg University Hospital / National Center for Tumor Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise - Social Media, Exercise - App and Exercise - closed to patients residence in people with Fatigue and Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the three exercise interventions (time frame: During 12 week of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.