CancerMOVE-ONKONCT06185777
Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients
A study testing Exercise oncology counseling and referal in people with Cancer and Exercise, run by University Hospital Heidelberg at 7 sites in Germany.
Trial summary
MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Exercise, Implementation
- What is being tested?
- Exercise oncology counseling and referal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 7 sitesGermany
- Study dates
- 1 Dec 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cancer patients during chemotherapy, immune therapy or radiotherapy
- having symptoms/side effects that can be effectively treated by exercise (e.g. fatigue) and/or are interested in exercise oncology counseling
- involved in the implementation process
Who cannot join
- Insufficient German language skills
- Duration employed <6 months
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Bernd Wolfarth, Prof., +49 30 2093-46053, bernd.wolfarth@charite.de
- Recruiting
Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)
Dresden, Saxony, 01307
Martin Bornhäuser, Prof., +351 458 4190, martin.bornhaeuser@uniklinikum-dresden.de
- Recruiting
Universitäres Centrum für Tumorekrankungen Frankfurt
Frankfurt am Main, Hesse, 60488
Katharina Graf, Dr, +49 69 7601 3380, graf.katharina@khnw.de
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Tanja Sprave, Dr, +49 761 270-95200|, tanja.sprave@uniklinik-freiburg.de
- Recruiting
Nationales Centrum für Tumorerkrankungen
Heidelberg, Baden-Wurttemberg, 69120
Joachim Wiskemann, Prof., +49 6221 56 5904, joachim.wiskemann@nct-heidelberg.de
- Recruiting
Universitäres Centrum für Tumorerkrankungen Mainz
Mainz, Rhineland-Palatinate, 55131
Ulrich Betz, Dr., +49 6131 17-2356, ulrich.betz@unimedizin-mainz.de
- Recruiting
Medizinische Klinik der Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Andreas Nieß, Prof., +49 7071-29 86472, andreas.niess@med.uni-tuebingen.de
About this study
MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible.
The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients
- Conditions
- Cancer, Exercise, Implementation
- Being tested
- Exercise oncology counseling and referal
- Keywords
- Cancer, Cancer treatment, Exercise, Physical Activity, Counseling, Cancer Care, Implementation, Nursing
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise oncology counseling and referalBehavioural
Identification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Exercise oncology counseling and referal | Experimental | Identification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy Receives: Behavioral: Exercise oncology counseling and referal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30
Physical Function will be assessed within the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises 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. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symptom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 12 Score - Baseline Score)
Measured: baseline till week 12 (& 12 week follow up)
Secondary outcomes (9)
Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin Leisure-Time Exercise Questionnaire assesses self-reported physical activity (PA) among adults in minutes per week (3 intensity categories: low, moderate, vigorous)
Measured: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in physical activity-related health competence
The questionnaire is based on the physical activity-related health competence (PAHCO) model by Sudeck and Pfeifer et al. 2016 and supposed to assess specific facets of the PAHCO, specifically addressing an individual's aptitude to effectively utilize physical activity to optimize their overall health. The questionnaire consists of 13 items comprised of three latent factors: PA-specific mood regulation (MR) (four items), control competence for physical training (CC) (six items) and PA specific self-control (SC) (three items)
Measured: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in social support
The Modified Medical Outcomes Study Social Support Survey (mMOS-SS) is an 8-item self-reported measure of individual experience of social support, with two subscale measures of emotional support, and instrumental support. Items ask respondents about having someone to help with physical needs, and emotional assistance. The mMOS-SS is an abbreviated adaptation of the original 19-item
Measured: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in patient activation
PAM is a validated questionnaire designed to measure the knowledge, skills and confidence that a person has to manage their own wellbeing (patient activation).
Measured: baseline till week 12 (& 12 week follow up)
Patients' Experiences Across Health Care Sectors at week 12
The Patients' Experiences Across Health Care Sectors (PEACS) questionnaire is a validated questionnaire to asses patient orientation in a fragmented health-care system
Measured: week 12
Patients' Shared Decision-Making experience at week 12
The 9-item Shared Decision Making Questionnaire was developed in a theory-driven manner and measures the extent to which patients are involved in the process of decision-making from the perspective of the patient (patient version SDM-Q-9) and from the perspective of the physician (physician version SDM-Q-Doc). The measure was developed for use in research and clinical practice.
Measured: week 12
Reasons for discontinuing physical/exercise therapy at week 12 and follow-up
The Problematic Experiences of Therapy Scale (PETS; Kirby, Donovan-Hall, \& Yardley, 2014) is a brief measure that was developed based on clinical experience and research to reflect the most commonly reported reasons for discontinuing physical therapy given by patients undergoing self-managed home-based rehabilitation. he PETS comprises 12 Likert-scaled items divided into four subscales: 1. Symptoms too severe or aggravated by therapy (items 1-3), 2. Uncertainty about how to carry out the treatment (items 4-5), 3. Doubts about treatment efficacy (items 6-8), and 4. Practical problems (items 9-12). Each item asks respondents the extent to which they agree that they have been prevented from carrying out an intervention by plausible reasons.
Measured: week 12 (& 12 week follow up)
Cancer Patients Information Needs at week 12 and follow-up
Cancer Patients Information Needs" scale is a validated 17-item questionnaire (Mesters et al. 2001) assessing the various needs of cancer patients during and after cancer treatment
Measured: week 12 (& 12 week follow up)
Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy
Various measures specific to the implemented intervention
Measured: baseline till week 12 (& 12 week follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185777
- Sponsor's protocol ID
- S-571/2023
- Acronym
- MOVE-ONKO
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2023
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blutgen S, Tigges AL, Zinkevich A, Krug K, Wensing M, Graf K, Wiskemann J, Ansmann L; MOVE-ONKO Consortium. 'It only works if we coordinate our work, that's what we need': a relational qualitative network analysis of exercise therapy in oncology care in Germany. BMC Cancer. 2025 Nov 29;25(1):1845. doi: 10.1186/s12885-025-15326-y.
PubMed 41318435Blutgen S, Krug K, Graf K, Betz U, Bohm J, Jager E, Krell V, Muller J, Pahl A, Voland A, Weigmann-Fassbender S, Zinkevich A, Wensing M, Ansmann L, Wiskemann J. Implementation and evaluation of a multi-professional care pathway and network for the promotion of needs-oriented, resident-oriented exercise therapy for oncological patients (MOVE-ONKO): protocol of a mixed-methods cohort study. BMC Cancer. 2025 Mar 13;25(1):458. doi: 10.1186/s12885-025-13797-7.
PubMed 40082847
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients
- ClinicalTrials.gov ID
- NCT06185777
- Acronym / sponsor ID
- MOVE-ONKO / S-571/2023
- Conditions
- Cancer, Exercise, Implementation
- Keywords
- Cancer, Cancer treatment, Exercise, Physical Activity, Counseling, Cancer Care, Implementation, Nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 Dec 2023 (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.
MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible.
The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise oncology counseling and referal | Experimental | Behavioral: Exercise oncology counseling and referalIdentification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cancer patients during chemotherapy, immune therapy or radiotherapy
- having symptoms/side effects that can be effectively treated by exercise (e.g. fatigue) and/or are interested in exercise oncology counseling
- involved in the implementation process
Key exclusion criteria (2 listed)
- Insufficient German language skills
- Duration employed <6 months
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 oncology counseling and referalIdentification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy | Behavioural | Exercise oncology counseling and referal |
Primary outcome
Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30
Time frame: baseline till week 12 (& 12 week follow up)
Physical Function will be assessed within the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises 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. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symptom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 12 Score - Baseline Score)
9 secondary outcomes
Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in physical activity-related health competence
Time frame: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in social support
Time frame: baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in patient activation
Time frame: baseline till week 12 (& 12 week follow up)
Patients' Experiences Across Health Care Sectors at week 12
Time frame: week 12
Patients' Shared Decision-Making experience at week 12
Time frame: week 12
Reasons for discontinuing physical/exercise therapy at week 12 and follow-up
Time frame: week 12 (& 12 week follow up)
Cancer Patients Information Needs at week 12 and follow-up
Time frame: week 12 (& 12 week follow up)
Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy
Time frame: baseline till week 12 (& 12 week follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 41318435Blutgen S, Tigges AL, Zinkevich A, Krug K, Wensing M, Graf K, Wiskemann J, Ansmann L; MOVE-ONKO Consortium. 'It only works if we coordinate our work, that's what we need': a relational qualitative network analysis of exercise therapy in oncology care in Germany. BMC Cancer. 2025 Nov 29;25(1):1845. doi: 10.1186/s12885-025-15326-y.
- Derived from this study: PubMed 40082847Blutgen S, Krug K, Graf K, Betz U, Bohm J, Jager E, Krell V, Muller J, Pahl A, Voland A, Weigmann-Fassbender S, Zinkevich A, Wensing M, Ansmann L, Wiskemann J. Implementation and evaluation of a multi-professional care pathway and network for the promotion of needs-oriented, resident-oriented exercise therapy for oncological patients (MOVE-ONKO): protocol of a mixed-methods cohort study. BMC Cancer. 2025 Mar 13;25(1):458. doi: 10.1186/s12885-025-13797-7.
- Project Website (in German only)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise oncology counseling and referal in people with Cancer and Exercise, run by University Hospital Heidelberg at 7 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim Wiskemann, Prof (+49 6221 565904, joachim.wiskemann@nct-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30 (time frame: baseline till week 12 (& 12 week follow up)). 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 NCT06185777, which also lists 2 linked publications.
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 3 Feb 2025.