IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients
NCT Number: NCT06496711
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients
Sponsor: University of Cologne
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
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2026-02-28
Locations: University Hospital Cologne, Cologne, 50937, Germany

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.

Primary Outcome Measures: 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., Baseline (M1), one year (M2) and 2 years (M3)
Secondary Outcome Measures: 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., 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., 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., 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., Baseline (M1), one year (M2) and 2 years (M3)