Clinical trial NCT06496711: IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients
Official title: IMPLEMENT - Model Project for the Cross-sector Implementation of a Comprehensive and Quality-assured Sports and Exercise Therapy for Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: exercise therapy
Implementation
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
name: University of Regensburg
name: Ludwig-Maximilians - University of Munich
name: Technical University of Munich
name: Martin-Luther-Universität Halle-Wittenberg
name: University Hospital Schleswig-Holstein
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital, Essen
First posted: 2024-07-11
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: explorative, open, non-randomised mixed-methods study
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients with cancer
* Healthcare providers (e.g. Medical Doctors, physiotherapists, nurses, psychologists) involved in the treatment and/or counseling of cancer patients, including aftercare.

Exclusion Criteria (Cancer Patients):

* Psychological and/or physical limitations that do not allow participation in quality-assured sports and exercise therapy (e.g. unstable cardiac arrhythmias)

Primary outcomes:
measure: Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy
timeFrame: Baseline (M1), one year (M2) and 2 years (M3)
Secondary outcomes:
measure: SO1. Adoption/acceptance
timeFrame: Baseline (M1), one year (M2) and 2 years (M3)
measure: SO2. Patient-related effectiveness
timeFrame: Baseline (M1), one year (M2) and 2 years (M3)
measure: SO3. Consistency of implementation
timeFrame: Baseline (M1), one year (M2) and 2 years (M3)
measure: SO4. Maintenance
timeFrame: Baseline (M1), one year (M2) and 2 years (M3)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
Study officials:
affiliation: University of Cologne
name: Freerk Baumann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg
name: Michael Leitzmann, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
name: Hajo Zeeb, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: