Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients

NCT06185777 | Recruiting

• 1 other identifier: S-571/2023
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 7

Brief Summary

MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible. The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients

Conditions

Cancer; Exercise; Implementation

Keywords

Cancer; Cancer treatment; Exercise; Physical Activity; Counseling; Cancer Care; Implementation; Nursing

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30

  Physical Function will be assessed within the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symptom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 12 Score - Baseline Score)

  baseline till week 12 (& 12 week follow up)

Secondary Outcomes (9)

• Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire

  baseline till week 12 (& 12 week follow up)

• Change from baseline to week 12 in physical activity-related health competence

  baseline till week 12 (& 12 week follow up)

• Change from baseline to week 12 in social support

  baseline till week 12 (& 12 week follow up)

• Change from baseline to week 12 in patient activation

  baseline till week 12 (& 12 week follow up)

• Patients' Experiences Across Health Care Sectors at week 12

  week 12

Study Arms (1)

Exercise oncology counseling and referal

EXPERIMENTAL

Identification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy

Behavioral: Exercise oncology counseling and referal

Interventions

Exercise oncology counseling and referal BEHAVIORAL

Identification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy

Exercise oncology counseling and referal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer patients during chemotherapy, immune therapy or radiotherapy
• having symptoms/side effects that can be effectively treated by exercise (e.g. fatigue) and/or are interested in exercise oncology counseling
• \- involved in the implementation process

You may not qualify if:

• \- Insufficient German language skills
• \- Duration employed \<6 months

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (7)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Nationales Centrum für Tumorerkrankungen

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Medizinische Klinik der Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitäres Centrum für Tumorekrankungen Frankfurt

Frankfurt am Main, Hesse, 60488, Germany

RECRUITING

Universitäres Centrum für Tumorerkrankungen Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)

Dresden, Saxony, 01307, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (2)

• Blutgen S, Tigges AL, Zinkevich A, Krug K, Wensing M, Graf K, Wiskemann J, Ansmann L; MOVE-ONKO Consortium. 'It only works if we coordinate our work, that's what we need': a relational qualitative network analysis of exercise therapy in oncology care in Germany. BMC Cancer. 2025 Nov 29;25(1):1845. doi: 10.1186/s12885-025-15326-y.

  PMID: 41318435 DERIVED

• Blutgen S, Krug K, Graf K, Betz U, Bohm J, Jager E, Krell V, Muller J, Pahl A, Voland A, Weigmann-Fassbender S, Zinkevich A, Wensing M, Ansmann L, Wiskemann J. Implementation and evaluation of a multi-professional care pathway and network for the promotion of needs-oriented, resident-oriented exercise therapy for oncological patients (MOVE-ONKO): protocol of a mixed-methods cohort study. BMC Cancer. 2025 Mar 13;25(1):458. doi: 10.1186/s12885-025-13797-7.

  PMID: 40082847 DERIVED

Related Links

• Project Website (in German only)

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Joachim Wiskemann, Prof

CONTACT

+49 6221 565904; joachim.wiskemann@nct-heidelberg.de

Julia Albrecht, Dr

CONTACT

+49 6221 56-32630; julia.albrecht@nct-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Joachim Wiskemann

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)