To hear about similar clinical trials, please enter your email below
Trial Title:
IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients
NCT ID:
NCT06496711
Condition:
Cancer
Conditions: Keywords:
exercise therapy
Implementation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
explorative, open, non-randomised mixed-methods study
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients
Description:
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.
Arm group label:
Cancer Patients and Parents of Cancer Patients
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.
Criteria for 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)
Gender:
All
Minimum age:
5 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Cologne
Address:
City:
Cologne
Zip:
50937
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Freerk Baumann, Prof. Dr.
Phone:
+4922147842646
Email:
freerk.baumann@uk-koeln.de
Contact backup:
Last name:
Anika Berling-Ernst, Dr.
Phone:
+4922147842646
Email:
anika.berling-ernst@uk-koeln.de
Start date:
September 1, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
University of Cologne
Agency class:
Other
Collaborator:
Agency:
Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
Agency class:
Other
Collaborator:
Agency:
University of Regensburg
Agency class:
Other
Collaborator:
Agency:
Ludwig-Maximilians - University of Munich
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Martin-Luther-Universität Halle-Wittenberg
Agency class:
Other
Collaborator:
Agency:
University Hospital Schleswig-Holstein
Agency class:
Other
Collaborator:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Collaborator:
Agency:
University Hospital, Essen
Agency class:
Other
Source:
University of Cologne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496711
