CancerNCT06496711
IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients
A study testing Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients in people with Cancer, run by University of Cologne at 1 site in Germany.
Trial summary
IMPLEMENT aims to develop, test and establish a sustainable access structure for quality-assured oncological exercise therapy (qOET) in Germany as a model within the funding period of three years. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 28 Feb 2026
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cancer
- Healthcare providers (e.g. Medical Doctors, physiotherapists, nurses, psychologists) involved in the treatment and/or counseling of cancer patients, including aftercare.
Who cannot join
- Psychological and/or physical limitations that do not allow participation in quality-assured sports and exercise therapy (e.g. unstable cardiac arrhythmias)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, 50937
Freerk Baumann, Prof. Dr., +4922147842646, freerk.baumann@uk-koeln.de
Anika Berling-Ernst, Dr., +4922147842646, anika.berling-ernst@uk-koeln.de
About this study
Official title: IMPLEMENT - Model Project for the Cross-sector Implementation of a Comprehensive and Quality-assured Sports and Exercise Therapy for Cancer Patients
IMPLEMENT aims to develop, test and establish a sustainable access structure for quality-assured oncological exercise therapy (qOET) in Germany as a model within the funding period of three years. This will be done in three phases:
Phase 1: In the first step, a characterization of the existing implementation structures and the existing barriers and needs as well as the establishment of the cooperation with the most important actors in the care system will take place.
Read more
Phase 2: In the subsequent implementation process, concrete measures are practically implemented in subprojects for specific target groups (children/adolescents, adults) and specific regions (rural, urban) as well as the digital solutions and interface management. With the help of a mixed-methods design, the barriers and facilitating factors of the implementation of area-wide qSBT will be investigated during the project and fed into a "learning system" for adaptation and improvement.
Phase 3: The success of the measures to increase patient participation in qOET and the development of the structures as well as the barrier and facilitating factors for an effective implementation will be addressed in a before-after comparison through evaluation steps and an economic accompanying evaluation will be carried out.
Read the detailed description
IMPLEMENT is an exploratory, open-label, non-randomized, mixed-methods study. No additional treatments or therapies that can influence the course of the disease are provided to the participating patients. Rather, various implementation strategies will be developed to bring more patients into the existing quality-assures oncological exercise therapy (qOET), to further develop other exercise and sports offers for qOET or to create completely new offers of qOET. The implementation strategies are examined with regard to their degree of effectiveness. The effectiveness is determined by means of a before-and-after comparison (e.g. number of patients in qOET at baseline) and, if applicable, with comparable studies. IMPLEMENT is evaluated using the RE-AIM framework. The aim of the data collection carried out in IMPLEMENT is to provide the necessary data for the evaluation with RE-AIM on the one hand, and to provide information for the development and adaptation of suitable implementation strategies on the other.
Risks to achieving the objectives include the willingness of patients to participate in qOET and the willingness of doctors, therapists and other people working in oncological care to implement the interventions and to expand and adapt their professional activities accordingly. To address these challenges, a mixed-methods approach is used to identify barriers and facilitators. A mixed-methods approach enables a theoretical understanding of the implementation process and provides a more comprehensive picture of the factors relevant to successful implementation than qualitative or exclusively quantitative methods alone.
- Conditions
- Cancer
- Being tested
- Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients
- Keywords
- exercise therapy, Implementation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patientsOther
The study population will be surveyed at 3 yearly measurement time points by means of questionnaires and interviews on attitudes, barrier and support factors for participation in exercise therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients and Parents of Cancer Patients | Other | Children: Age 5-12 years Parents of children with cancer Teenager: Age 13-17 years Parents of teenager with cancer AYAs: Adolescence and young adults: Age 18-39 years Adults: > 40 years Receives: Other: Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy
The primary outcome of the IMPLEMENT project is an increase in the number of oncology patients participating in quality-assured sports and exercise therapy (median 30%). The primary outcome is measured by the RE-AIM (Reach) questionnaire in a semi-structured personal interview three times.
Measured: Baseline (M1), one year (M2) and 2 years (M3)
Secondary outcomes (4)
SO1. Adoption/acceptance
Indicator: Other IMPLEMENT locations or institutions offer quality-assured exercise therapy.
Indicator: The existing quality-assured exercise therapy service is offered to other oncology patient groups.
These outcomes are measured using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) questionnaire in a semi-structured personal interview three times. We report the overall numbers, higher is better.
Measured: Baseline (M1), one year (M2) and 2 years (M3)
SO2. Patient-related effectiveness
Indicator: Proportion of patients who report a positive impact of exercise therapy on their daily lives (increase of 25% over the course of the project).
Patient-related effectiveness is measured using the quality of life questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) for adults and Pediatric Quality of Life Inventory™ Version 4.0. (PedsQL™ 4.0) for children and adolescents. The EORTC QLQ-C30 is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. The 23-item PedsQL™ 4.0 measures health-related quality of life (HRQoL) in children and adolescents across multiple dimensions, including physical, emotional, social, and school functioning. Results will be transformed into scores on a 0-100 scale, with higher scores indicating better HRQoL.
Measured: Baseline (M1), one year (M2) and 2 years (M3)
SO3. Consistency of implementation
Indicator: At all IMPLEMENT locations and institutions, a) participation in the standardized IMPLEMENT further education and training program is offered at the IMPLEMENT location in Cologne (face-to-face or online) and b) if the institution offers quality-assured exercise therapy, the standardized further education and training program is taken up by at least 50% of the therapists working in quality-assured exercise therapy.
Indicator: At all institutions that offer quality-assured exercise therapy, at least 80% of patients are informed about the offer.
These outcomes are measured using the RE-AIM (Consistency of implementation) questionnaire in a semi-structured personal interview three times. We report proportions, 0-100%, higher is better.
Measured: Baseline (M1), one year (M2) and 2 years (M3)
SO4. Maintenance
Indicator: Quality-assured exercise therapy can be offered beyond the course of the project at all IMPLEMENT locations and institutions that started quality-assured exercise therapy during the course of the project.
Indicator: Information on financing models (e.g. with health insurance companies) from all IMPLEMENT locations and institutions has been summarized centrally in IMPLEMENT and is included in the recommendations for the sustainable implementation of quality-assured exercise therapy.
These outcomes are measured using the RE-AIM (Maintenance) questionnaire in a semi-structured personal interview three times. We report proportions, 0-100%, higher is better.
Measured: Baseline (M1), one year (M2) and 2 years (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Sep 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- explorative, open, non-randomised mixed-methods study
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH, University of Regensburg, Ludwig-Maximilians - University of Munich, Technical University of Munich, Martin-Luther-Universität Halle-Wittenberg, University Hospital Schleswig-Holstein, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Essen
- Responsible party
- Principal investigator, Freerk Baumann; Prof. Dr., University of Cologne
- Investigators
- Freerk Baumann, Prof. Dr., Principal investigator, University of CologneMichael Leitzmann, Prof.Dr.Dr., Principal investigator, University of RegensburgHajo Zeeb, Prof. Dr., Principal investigator, Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496711
- Sponsor's protocol ID
- UCologne 70114696
- Status last verified
- Aug 2024
- First submitted
- 22 May 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morlok D, Ruter J, Illmann M, Bieniosek L, Welker C, Reitz M, Meuer J, Okon T, Baurecht H, Herr W, Pukrop T, Brandes M, Berling-Ernst A, Sell L, Jensen W, Zimmer R, Schmidt H, Wagemann F, Stark R, Kleinhenz A, Madl B, Zeeb H, Leitzmann M, Baumann FT, Herrmann A; IMPLEMENT consortium. A qualitative analysis of cancer patients' views on facilitators and barriers for the implementation of oncological exercise therapy. Support Care Cancer. 2026 Jul 14;34(8):762. doi: 10.1007/s00520-026-10957-8.
PubMed 42446746Morlok D, Bieniosek L, Baurecht H, Reitz M, Okon T, Meuer J, Welker C, Herr W, Pukrop T, Einhell S, Berling-Ernst A, Wehner A, Brandes M, Theurich S, Madl B, Sell L, Schmidt T, Jahn P, Evers C, Zimmer R, Stark R, Zeeb H, Leitzmann M, Baumann FT, Herrmann A. A multi-center cross-sectional study to explore cancer patients' views on facilitators and barriers for the implementation of oncological exercise therapy. Front Oncol. 2026 Jun 10;16:1800417. doi: 10.3389/fonc.2026.1800417. eCollection 2026.
PubMed 42358533
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPLEMENT - Model Project for the Cross-sector Implementation of a Comprehensive and Quality-assured Sports and Exercise Therapy for Cancer Patients
- ClinicalTrials.gov ID
- NCT06496711
- Acronym / sponsor ID
- UCologne 70114696
- Conditions
- Cancer
- Keywords
- exercise therapy, Implementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH, University of Regensburg, Ludwig-Maximilians - University of Munich, Technical University of Munich, Martin-Luther-Universität Halle-Wittenberg, University Hospital Schleswig-Holstein, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Essen
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 11 Jul 2024 (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.
IMPLEMENT aims to develop, test and establish a sustainable access structure for quality-assured oncological exercise therapy (qOET) in Germany as a model within the funding period of three years. This will be done in three phases:
Phase 1: In the first step, a characterization of the existing implementation structures and the existing barriers and needs as well as the establishment of the cooperation with the most important actors in the care system will take place.
Phase 2: In the subsequent implementation process, concrete measures are practically implemented in subprojects for specific target groups (children/adolescents, adults) and specific regions (rural, urban) as well as the digital solutions and interface management. With the help of a mixed-methods design, the barriers and facilitating factors of the implementation of area-wide qSBT will be investigated during the project and fed into a "learning system" for adaptation and improvement.
Phase 3: The success of the measures to increase patient participation in qOET and the development of the structures as well as the barrier and facilitating factors for an effective implementation will be addressed in a before-after comparison through evaluation steps and an economic accompanying evaluation will be carried out.
Detailed description
IMPLEMENT is an exploratory, open-label, non-randomized, mixed-methods study. No additional treatments or therapies that can influence the course of the disease are provided to the participating patients. Rather, various implementation strategies will be developed to bring more patients into the existing quality-assures oncological exercise therapy (qOET), to further develop other exercise and sports offers for qOET or to create completely new offers of qOET. The implementation strategies are examined with regard to their degree of effectiveness. The effectiveness is determined by means of a before-and-after comparison (e.g. number of patients in qOET at baseline) and, if applicable, with comparable studies. IMPLEMENT is evaluated using the RE-AIM framework. The aim of the data collection carried out in IMPLEMENT is to provide the necessary data for the evaluation with RE-AIM on the one hand, and to provide information for the development and adaptation of suitable implementation strategies on the other.
Risks to achieving the objectives include the willingness of patients to participate in qOET and the willingness of doctors, therapists and other people working in oncological care to implement the interventions and to expand and adapt their professional activities accordingly. To address these challenges, a mixed-methods approach is used to identify barriers and facilitators. A mixed-methods approach enables a theoretical understanding of the implementation process and provides a more comprehensive picture of the factors relevant to successful implementation than qualitative or exclusively quantitative methods alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- explorative, open, non-randomised mixed-methods study
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients and Parents of Cancer Patients | Other | Other: Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patientsChildren: Age 5-12 years Parents of children with cancer Teenager: Age 13-17 years Parents of teenager with cancer AYAs: Adolescence and young adults: Age 18-39 years Adults: > 40 years |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cancer
- Healthcare providers (e.g. Medical Doctors, physiotherapists, nurses, psychologists) involved in the treatment and/or counseling of cancer patients, including aftercare.
Key exclusion criteria (1 listed)
- Psychological and/or physical limitations that do not allow participation in quality-assured sports and exercise therapy (e.g. unstable cardiac arrhythmias)
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 |
|---|---|---|
| Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patientsThe study population will be surveyed at 3 yearly measurement time points by means of questionnaires and interviews on attitudes, barrier and support factors for participation in exercise therapy. | Other | Cancer Patients and Parents of Cancer Patients |
Primary outcome
Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy
Time frame: Baseline (M1), one year (M2) and 2 years (M3)
The primary outcome of the IMPLEMENT project is an increase in the number of oncology patients participating in quality-assured sports and exercise therapy (median 30%). The primary outcome is measured by the RE-AIM (Reach) questionnaire in a semi-structured personal interview three times.
4 secondary outcomes
SO1. Adoption/acceptance
Time frame: Baseline (M1), one year (M2) and 2 years (M3)
SO2. Patient-related effectiveness
Time frame: Baseline (M1), one year (M2) and 2 years (M3)
SO3. Consistency of implementation
Time frame: Baseline (M1), one year (M2) and 2 years (M3)
SO4. Maintenance
Time frame: Baseline (M1), one year (M2) and 2 years (M3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42446746Morlok D, Ruter J, Illmann M, Bieniosek L, Welker C, Reitz M, Meuer J, Okon T, Baurecht H, Herr W, Pukrop T, Brandes M, Berling-Ernst A, Sell L, Jensen W, Zimmer R, Schmidt H, Wagemann F, Stark R, Kleinhenz A, Madl B, Zeeb H, Leitzmann M, Baumann FT, Herrmann A; IMPLEMENT consortium. A qualitative analysis of cancer patients' views on facilitators and barriers for the implementation of oncological exercise therapy. Support Care Cancer. 2026 Jul 14;34(8):762. doi: 10.1007/s00520-026-10957-8.
- Derived from this study: PubMed 42358533Morlok D, Bieniosek L, Baurecht H, Reitz M, Okon T, Meuer J, Welker C, Herr W, Pukrop T, Einhell S, Berling-Ernst A, Wehner A, Brandes M, Theurich S, Madl B, Sell L, Schmidt T, Jahn P, Evers C, Zimmer R, Stark R, Zeeb H, Leitzmann M, Baumann FT, Herrmann A. A multi-center cross-sectional study to explore cancer patients' views on facilitators and barriers for the implementation of oncological exercise therapy. Front Oncol. 2026 Jun 10;16:1800417. doi: 10.3389/fonc.2026.1800417. eCollection 2026.
- 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. This study is not recruiting at the moment.
Freerk Baumann, Prof. Dr. principal investigator
University of Cologne
Michael Leitzmann, Prof.Dr.Dr. principal investigator
University of Regensburg
Hajo Zeeb, Prof. Dr. principal investigator
Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients in people with Cancer, run by University of Cologne 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 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Freerk Baumann, Prof. Dr. (0049 0221 478 42646, freerk.baumann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy (time frame: Baseline (M1), one year (M2) and 2 years (M3)). 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 NCT06496711, 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 23 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.