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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Exercise; Implementation
• Intervention / Treatment: Behavioral: Exercise oncology counseling and referal

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joachim Wiskemann, Prof; Phone Number: +49 6221 565904; Email: joachim.wiskemann@nct-heidelberg.de
• Study Contact Backup: Name: Julia Albrecht, Dr; Phone Number: +49 6221 56-32630; Email: julia.albrecht@nct-heidelberg.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Bernd Wolfarth, Prof.; Phone Number: +49 30 2093-46053; Email: bernd.wolfarth@charite.de
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Recruiting
      • Universitätsklinikum Freiburg
      • Contact: Tanja Sprave, Dr; Phone Number: +49 761 270-95200|; Email: tanja.sprave@uniklinik-freiburg.de
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • Nationales Centrum für Tumorerkrankungen
      • Contact: Joachim Wiskemann, Prof.; Phone Number: +49 6221 56 5904; Email: joachim.wiskemann@nct-heidelberg.de
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • Medizinische Klinik der Universitätsklinikum Tübingen
      • Contact: Andreas Nieß, Prof.; Phone Number: +49 7071-29 86472; Email: andreas.niess@med.uni-tuebingen.de
  • Hessen
    • Frankfurt, Hessen, Germany, 60488
      • Recruiting
      • Universitäres Centrum für Tumorekrankungen Frankfurt
      • Contact: Katharina Graf, Dr; Phone Number: +49 69 7601 3380; Email: graf.katharina@khnw.de
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Universitäres Centrum für Tumorerkrankungen Mainz
      • Contact: Ulrich Betz, Dr.; Phone Number: +49 6131 17-2356; Email: ulrich.betz@unimedizin-mainz.de
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Recruiting
      • Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)
      • Contact: Martin Bornhäuser, Prof.; Phone Number: +351 458 4190; Email: martin.bornhaeuser@uniklinikum-dresden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (patients):

• 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

Inclusion Criteria (care providers)

- involved in the implementation process

Exclusion Criteria (both):

- Insufficient German language skills

Exclusion Criteria (care providers only):

- Duration employed <6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise oncology counseling and referal; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire	The Godin Leisure-Time Exercise Questionnaire assesses self-reported physical activity (PA) among adults in minutes per week (3 intensity categories: low, moderate, vigorous)	baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in physical activity-related health competence	The questionnaire is based on the physical activity-related health competence (PAHCO) model by Sudeck and Pfeifer et al. 2016 and supposed to assess specific facets of the PAHCO, specifically addressing an individual's aptitude to effectively utilize physical activity to optimize their overall health. The questionnaire consists of 13 items comprised of three latent factors: PA-specific mood regulation (MR) (four items), control competence for physical training (CC) (six items) and PA specific self-control (SC) (three items)	baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in social support	The Modified Medical Outcomes Study Social Support Survey (mMOS-SS) is an 8-item self-reported measure of individual experience of social support, with two subscale measures of emotional support, and instrumental support. Items ask respondents about having someone to help with physical needs, and emotional assistance. The mMOS-SS is an abbreviated adaptation of the original 19-item	baseline till week 12 (& 12 week follow up)
Change from baseline to week 12 in patient activation	PAM is a validated questionnaire designed to measure the knowledge, skills and confidence that a person has to manage their own wellbeing (patient activation).	baseline till week 12 (& 12 week follow up)
Patients' Experiences Across Health Care Sectors at week 12	The Patients' Experiences Across Health Care Sectors (PEACS) questionnaire is a validated questionnaire to asses patient orientation in a fragmented health-care system	week 12
Patients' Shared Decision-Making experience at week 12	The 9-item Shared Decision Making Questionnaire was developed in a theory-driven manner and measures the extent to which patients are involved in the process of decision-making from the perspective of the patient (patient version SDM-Q-9) and from the perspective of the physician (physician version SDM-Q-Doc). The measure was developed for use in research and clinical practice.	week 12
Reasons for discontinuing physical/exercise therapy at week 12 and follow-up	The Problematic Experiences of Therapy Scale (PETS; Kirby, Donovan-Hall, & Yardley, 2014) is a brief measure that was developed based on clinical experience and research to reflect the most commonly reported reasons for discontinuing physical therapy given by patients undergoing self-managed home-based rehabilitation. he PETS comprises 12 Likert-scaled items divided into four subscales: 1. Symptoms too severe or aggravated by therapy (items 1-3), 2. Uncertainty about how to carry out the treatment (items 4-5), 3. Doubts about treatment efficacy (items 6-8), and 4. Practical problems (items 9-12). Each item asks respondents the extent to which they agree that they have been prevented from carrying out an intervention by plausible reasons.	week 12 (& 12 week follow up)
Cancer Patients Information Needs at week 12 and follow-up	Cancer Patients Information Needs" scale is a validated 17-item questionnaire (Mesters et al. 2001) assessing the various needs of cancer patients during and after cancer treatment	week 12 (& 12 week follow up)
Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy	Various measures specific to the implemented intervention	baseline till week 12 (& 12 week follow up)

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Publications and helpful links

Helpful Links

• Project Website (in German only)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Cancer; Cancer treatment; Counseling; Implementation; Nursing; Cancer Care
• Other Study ID Numbers: S-571/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No