Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496711
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-22
Brief Title:
IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
IMPLEMENT - Model Project for the Cross-sector Implementation of a Comprehensive and Quality-assured Sports and Exercise Therapy for Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrenadolescents 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
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 childrenadolescents 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None