IMPLEMENT - Model Project for Quality-assured Exercise Therapy for Cancer Patients

NCT06496711 | Recruiting

• 1 other identifier: UCologne 70114696
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

exercise therapy; Implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• SO1. Adoption/acceptance

  Baseline (M1), one year (M2) and 2 years (M3)

• SO2. Patient-related effectiveness

  Baseline (M1), one year (M2) and 2 years (M3)

• SO3. Consistency of implementation

  Baseline (M1), one year (M2) and 2 years (M3)

• SO4. Maintenance

  Baseline (M1), one year (M2) and 2 years (M3)

Study Arms (1)

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

Other: Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients

Interventions

Cancer Patients; Institutions and their employees in the treatment and/or counseling of cancer patients OTHER

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.

Cancer Patients and Parents of Cancer Patients

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead
• Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH: collaborator
• University of Regensburg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Technical University of Munich: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital, Essen: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Academies and Institutes

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Freerk Baumann, Prof. Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

• Michael Leitzmann, Prof.Dr.Dr.

  University of Regensburg

  PRINCIPAL INVESTIGATOR

• Hajo Zeeb, Prof. Dr.

  Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Freerk Baumann, Prof. Dr.

CONTACT

0049 0221 478 42646; freerk.baumann@uk-koeln.de

Anika Berling-Ernst, Dr.

CONTACT

0049 0221 478 42646; anika.berling-ernst@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Freerk Baumann

Model Details: explorative, open, non-randomised mixed-methods study

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: July 11, 2024
• Study Start: September 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)